Medical device manufacturer
Boehringer Mannheim Corp.
Boehringer Mannheim Corp. holds 340 FDA 510(k) clearances across 144 product codes. Median elapsed review time is 49 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 340
- Product codes
- 144
- Median review
- 49 days
- Recall records
- 0
How does FDA spell Boehringer Mannheim Corp.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Boehringer Mannheim Corp. file in?
144 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 24 | 16 days | |
| CGA | Glucose Oxidase, Glucose | 17 | 92 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 17 | 29 days | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 16 | 45 days | |
| LFR | Glucose Dehydrogenase, Glucose | 9 | 86 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 8 | 37 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 7 | 42 days | |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 6 | 24 days | |
| KQO | Automated Urinalysis System | 6 | 56 days | |
| MMI | Immunoassay Method, Troponin Subunit | 6 | 54 days | |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 5 | 31 days | |
| JIS | Calibrator, Primary | 5 | 19 days | |
| KNK | Acid, Uric, Uricase (Colorimetric) | 5 | 33 days | |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 5 | 67 days | |
| CDP | Radioimmunoassay, Total Triiodothyronine | 4 | 62 days | |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 4 | 29 days | |
| JFY | Enzymatic Method, Creatinine | 4 | 31 days | |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 4 | 81 days | |
| KHS | Enzymatic, Carbon-Dioxide | 4 | 26 days | |
| KXT | Enzyme Immunoassay, Digoxin | 4 | 65 days | |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 3 | 49 days | |
| CEM | Electrode, Ion Specific, Potassium | 3 | 28 days | |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 3 | 25 days | |
| CIC | Cresolphthalein Complexone, Calcium | 3 | 18 days | |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 51 days |
Showing the 25 they file in most, of 144.
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 Boehringer Mannheim Corp. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Boehringer Mannheim Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K984326 | ELECYS IGE ASSAY | JHR | 67 | |
| K983047 | ACCU-CHEK HQ SYSTEM | LFR | 157 | |
| K984419 | ELECSYS IGE CALCHECK | JJY | 54 | |
| K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR | JIX | 40 | |
| K984372 | ELECSYS CALCHECK TROPONIN T | JJY | 7 | |
| K984105 | ELECSYS TROPONIN T STAT TEST | MMI | 21 | |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | CEO | 56 | |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | JIX | 55 | |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | DGC | 62 | |
| K983510 | CHEMSTRIP 101 URINE ANALYZER | KQO | 20 |
Source: openFDA device/510k · retrieved
Watch what Boehringer Mannheim Corp. files next
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