Diagnostic Reagents, Inc.: FDA clearances and approvals
Diagnostic Reagents, Inc. has 66 FDA 510(k) clearances (first 1982, latest 1998), across 39 product codes in 2 review panels. Median 510(k) review time: 58 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | 7 | 7 |
| DKB | Calibrators, Drug Mixture | 6 | 6 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 3 | 3 |
| DJR | Enzyme Immunoassay, Methadone | 3 | 3 |
| LCM | Enzyme Immunoassay, Phencyclidine | 3 | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 | 2 |
| JIS | Calibrator, Primary | 2 | 2 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 2 | 2 |
Plus 29 more product codes.
Review panels
- Clinical Toxicology (55)
- Clinical Chemistry (11)
Most recent Diagnostic Reagents, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | LFH | 1998-11-18 | 62 |
| K983812 | NAPA EIA ASSAY | LAN | 1998-11-16 | 19 |
| K983323 | DIGOXIN IMMUNOASSAY | KXT | 1998-11-12 | 51 |
| K983280 | VANCOMYCIN EIA ASSAY | LEH | 1998-11-06 | 49 |
| K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS | DKB | 1998-11-05 | 57 |
| K973102 | LIDOCAINE EIA ASSAY | KLR | 1997-09-12 | 24 |
| K972835 | 50NG/ML COCAINE METABOLITE CALIBRATOR | DLJ | 1997-08-28 | 28 |
| K972526 | METHADONE EIA ASSAY | DJR | 1997-08-04 | 39 |
| K964212 | QUINIDINE ENZYME IMMUNOASSAY | LBZ | 1996-12-18 | 57 |
| K963835 | DIGOXIN ENZYME IMMUNOASSAY | KXT | 1996-12-10 | 77 |
56 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Reagents, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Diagnostic Reagents, Inc. have?
Diagnostic Reagents, Inc. has 66 FDA 510(k) clearances (first 1982, latest 1998), across 39 product codes in 2 review panels.
How long does FDA take to clear Diagnostic Reagents, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Diagnostic Reagents, Inc.'s cleared 510(k)s is 58 days.
What devices does Diagnostic Reagents, Inc. make?
Its most frequent FDA product codes are DLJ (Calibrators, Drug Specific, 7); DKB (Calibrators, Drug Mixture, 6); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 3).
Has Diagnostic Reagents, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Diagnostic Reagents, Inc. Related entities may recall under other names.
Next steps
- See all 66 Diagnostic Reagents, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DLJ, Diagnostic Reagents, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.