Medical device manufacturer
Dade Behring, Inc.
Dade Behring, Inc. holds 343 FDA 510(k) clearances across 101 product codes. Median elapsed review time is 56 days. openFDA lists 29 recall records naming the company. FDA publishes it under 5 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 343
- Product codes
- 101
- Median review
- 56 days
- Recall records
- 29
How does FDA spell Dade Behring, Inc.?
FDA publishes this company under 5 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Dade Behring | device/recall | normalised |
| Dade Behring , Inc. | device/recall | normalised |
| Dade Behring Inc | device/recall | normalised |
| Dade Behring, Inc. | device/recall | normalised |
| Dade Behring, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Dade Behring, Inc. file in?
101 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 37 | 52 days | |
| JIT | Calibrator, Secondary | 29 | 28 days | |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 23 | 22 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 18 | 49 days | |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 12 | 79 days | |
| GKP | Instrument, Coagulation, Automated | 9 | 66 days | |
| DLJ | Calibrators, Drug Specific | 8 | 48 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 8 | 42 days | |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 8 | 46 days | |
| MMI | Immunoassay Method, Troponin Subunit | 7 | 77 days | |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 6 | 56 days | |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 6 | 82 days | |
| JIS | Calibrator, Primary | 6 | 45 days | |
| NBC | Test, Natriuretic Peptide | 6 | 54 days | |
| DDG | Transferrin, Antigen, Antiserum, Control | 5 | 103 days | |
| DKB | Calibrators, Drug Mixture | 5 | 47 days | |
| DKZ | Enzyme Immunoassay, Amphetamine | 5 | 67 days | |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 5 | 56 days | |
| NQD | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | 5 | 76 days | |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 | 63 days | |
| MKW | Cyclosporine | 4 | 30 days | |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 3 | 31 days | |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 61 days | |
| CZW | Complement C3, Antigen, Antiserum, Control | 3 | 71 days | |
| DCN | System, Test, C-Reactive Protein | 3 | 70 days |
Showing the 25 they file in most, of 101.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Dade Behring, Inc. had a recall?
openFDA lists 29 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0581-2009TerminatedJJE
Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.
Z-0485-2009TerminatedJFY
Reagent may exhibit unflagged inaccurate patient sample results.
Z-0668-2009TerminatedJHX
Incorrect result: Potential for false elevation of CTnI results
Z-1174-2007TerminatedJJE
Sample ID and Patient results could be associated with the wrong patient
Z-0247-2007TerminatedLIE
Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
Showing the 5 most recently initiated of 29.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Dade Behring, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | GGN | 369 | |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | CFN | 95 | |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | DEB | 80 | |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | DHX | 379 | |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | LOJ | 358 | |
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD | CEC | 83 | |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR | CFN | 69 | |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | JHM | 113 | |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | JFY | 65 | |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | DBA | 60 |
Source: openFDA device/510k · retrieved
Watch what Dade Behring, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.