Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Reagents, Inc. — Predicate Candidate Screening
66 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
125 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-18 | 62 | 0 |
| K983812 | NAPA EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-16 | 19 | 0 |
| K983323 | DIGOXIN IMMUNOASSAY | Diagnostic Reagents, Inc. | 1998-11-12 | 51 | 0 |
| K983280 | VANCOMYCIN EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-06 | 49 | 0 |
| K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS | Diagnostic Reagents, Inc. | 1998-11-05 | 57 | 0 |
| K973102 | LIDOCAINE EIA ASSAY | Diagnostic Reagents, Inc. | 1997-09-12 | 24 | 0 |
| K972835 | 50NG/ML COCAINE METABOLITE CALIBRATOR | Diagnostic Reagents, Inc. | 1997-08-28 | 28 | 0 |
| K972526 | METHADONE EIA ASSAY | Diagnostic Reagents, Inc. | 1997-08-04 | 39 | 0 |
| K964212 | QUINIDINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1996-12-18 | 57 | 0 |
| K963835 | DIGOXIN ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1996-12-10 | 77 | 0 |
| K962463 | PROCAINAMIDE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1996-08-14 | 50 | 0 |
| K961988 | VALPROIC ACID EIA TEST | Diagnostic Reagents, Inc. | 1996-07-16 | 56 | 0 |
| K961373 | ACETAMINOPHEN SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | 1996-07-08 | 90 | 0 |
| K961393 | TRICYCLICS SERUM TOX ASSAY | Diagnostic Reagents, Inc. | 1996-06-12 | 62 | 0 |
| K960708 | BENZODIAZEPINE SERUM TOX EIA TEST | Diagnostic Reagents, Inc. | 1996-05-20 | 89 | 0 |
| K961273 | AED CALIBRATORS | Diagnostic Reagents, Inc. | 1996-05-15 | 43 | 0 |
| K960664 | BARBITURATE SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | 1996-05-06 | 80 | 0 |
| K961372 | SERUM TOX CALIBRATOR | Diagnostic Reagents, Inc. | 1996-05-01 | 22 | 0 |
| K961131 | SALICYLATE ASSAY | Diagnostic Reagents, Inc. | 1996-04-29 | 39 | 1 |
| K960187 | COCAINE METABOLITE EIA TEST | Diagnostic Reagents, Inc. | 1996-04-02 | 77 | 1 |
| K960526 | PRIMIDONE EIA TEST | Diagnostic Reagents, Inc. | 1996-03-18 | 41 | 0 |
| K955928 | BARBITURATE EIA ESSAY (MODIFICATION) | Diagnostic Reagents, Inc. | 1996-03-11 | 84 | 0 |
| K955100 | CARBAMAZEPINE EIA TEST | Diagnostic Reagents, Inc. | 1995-12-13 | 35 | 0 |
| K952178 | PH-DETECT TEST | Diagnostic Reagents, Inc. | 1995-10-20 | 164 | 0 |
| K952596 | THEOPHYLLINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1995-08-11 | 66 | 0 |
| K951585 | T-UPTAKE CALIBRATORS | Diagnostic Reagents, Inc. | 1995-06-15 | 70 | 0 |
| K951586 | T-UPTAKE EIA TEST | Diagnostic Reagents, Inc. | 1995-05-15 | 39 | 0 |
| K946210 | PHENOBARBITAL ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1995-02-10 | 51 | 0 |
| K945725 | PHENYTION EIA TEST | Diagnostic Reagents, Inc. | 1995-02-03 | 73 | 0 |
| K945338 | THEOPHYLLINE CALIBRATORS | Diagnostic Reagents, Inc. | 1995-01-17 | 77 | 0 |
| K945316 | PHENOBARBITAL CALIBRATORS | Diagnostic Reagents, Inc. | 1995-01-04 | 64 | 0 |
| K944703 | THYROXINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1994-12-09 | 77 | 0 |
| K945337 | PHENYTOIN CALIBRATORS | Diagnostic Reagents, Inc. | 1994-12-07 | 36 | 0 |
| K944701 | CALIBRATORS | Diagnostic Reagents, Inc. | 1994-11-21 | 59 | 0 |
| K943998 | CANNABINOID EIA ASSAY | Diagnostic Reagents, Inc. | 1994-11-04 | 136 | 0 |
| K943414 | PROPOXPHENE EIA TEST | Diagnostic Reagents, Inc. | 1994-09-09 | 56 | 0 |
| K940935 | URINE CALIBRATOR | Diagnostic Reagents, Inc. | 1994-07-06 | 131 | 0 |
| K940123 | METHAQUALONE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1994-05-03 | 113 | 0 |
| K935101 | URINE CALIBRATORS AND CONTROLS MODIFICATION | Diagnostic Reagents, Inc. | 1994-01-27 | 99 | 0 |
| K934667 | METHADONE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1994-01-26 | 119 | 0 |
| K934891 | AMPHETAMINES EIA ASSAY MODIFICATION | Diagnostic Reagents, Inc. | 1994-01-13 | 114 | 0 |
| K935320 | PHENCYCLIDINE EIA ASSAY | Diagnostic Reagents, Inc. | 1993-12-29 | 76 | 0 |
| K935016 | COCAINE METABOLITE EIA ASSAY MODIFICATION | Diagnostic Reagents, Inc. | 1993-12-03 | 46 | 0 |
| K931780 | METHADONE METABOLITE EIA ASSAY | Diagnostic Reagents, Inc. | 1993-08-23 | 136 | 0 |
| K930529 | BENZODIAZEPINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1993-08-05 | 184 | 0 |
| K931506 | URINE CALIBRATOR AND CONTROL | Diagnostic Reagents, Inc. | 1993-07-28 | 125 | 0 |
| K932113 | CANNABINOID URINE CONTROLS | Diagnostic Reagents, Inc. | 1993-06-29 | 57 | 0 |
| K923783 | ETHYL ALCOHOL ASSAY | Diagnostic Reagents, Inc. | 1993-01-21 | 177 | 0 |
| K925491 | BARBITURATE EIA TEST | Diagnostic Reagents, Inc. | 1992-12-30 | 58 | 0 |
| K924733 | ETHYL ALCOHOL CALIBRATORS & CONTROL | Diagnostic Reagents, Inc. | 1992-12-09 | 78 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda