Medical device manufacturer
Beckman Instruments, Inc.
Beckman Instruments, Inc. holds 281 FDA 510(k) clearances across 145 product codes. Median elapsed review time is 50 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 281
- Product codes
- 145
- Median review
- 50 days
- Recall records
- 0
How does FDA spell Beckman Instruments, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Beckman Instruments, Inc. file in?
145 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 10 | 42 days | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 9 | 70 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 8 | 43 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 7 | 47 days | |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 7 | 21 days | |
| JJT | Enzyme Controls (Assayed And Unassayed) | 7 | 28 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 | 43 days | |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 | 15 days | |
| CEK | Biuret (Colorimetric), Total Protein | 4 | 50 days | |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 4 | 25 days | |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 | 22 days | |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 4 | 31 days | |
| DDG | Transferrin, Antigen, Antiserum, Control | 4 | 84 days | |
| DEW | Igg, Antigen, Antiserum, Control | 4 | 76 days | |
| DFH | Kappa, Antigen, Antiserum, Control | 4 | 35 days | |
| DHR | System, Test, Rheumatoid Factor | 4 | 34 days | |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 4 | 57 days | |
| MSJ | Apolipoproteins | 4 | 51 days | |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 19 days | |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 3 | 140 days | |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 3 | 64 days | |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 | 70 days | |
| JQY | Ph Meter | 3 | 45 days | |
| KLT | Enzyme Immunoassay, Carbamazepine | 3 | 66 days | |
| LCP | Assay, Glycosylated Hemoglobin | 3 | 98 days |
Showing the 25 they file in most, of 145.
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 Beckman Instruments, Inc. 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 Beckman Instruments, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 | LGD | 371 | |
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | CEC | 18 | |
| K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | DKB | 21 | |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | LOJ | 17 | |
| K980173 | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 | JHI | 57 | |
| K974816 | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 | LTJ | 59 | |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | DEB | 74 | |
| K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | JBQ | 54 | |
| K974452 | VIGIL LIPID CONTROL | JJY | 22 | |
| K973932 | BECKMAN CALIBRATOR 2 (CAL2) | JIX | 61 |
Source: openFDA device/510k · retrieved
Watch what Beckman Instruments, Inc. files next
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