Company ยท US
Diagnostic Reagents, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1998. Name variants (Inc, Corp, punctuation) are merged.
66510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DLJ | Calibrators, Drug Specific | 7 |
| DKB | Calibrators, Drug Mixture | 6 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 3 |
| DJR | Enzyme Immunoassay, Methadone | 3 |
| LCM | Enzyme Immunoassay, Phencyclidine | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 |
| JIS | Calibrator, Primary | 2 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 2 |
| KHQ | Radioassay, Triiodothyronine Uptake | 2 |
| KXT | Enzyme Immunoassay, Digoxin | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 |
| LFH | U.V. Spectrometry, Tricyclic Antidepressant Drugs | 2 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| DJP | Radioimmunoassay, Amphetamine | 1 |
| DKJ | Colorimetry, Salicylate | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 18, 1998 | K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY Diagnostic Reagents, Inc. | LFH |
| Nov 16, 1998 | K983812 | NAPA EIA ASSAY Diagnostic Reagents, Inc. | LAN |
| Nov 12, 1998 | K983323 | DIGOXIN IMMUNOASSAY Diagnostic Reagents, Inc. | KXT |
| Nov 6, 1998 | K983280 | VANCOMYCIN EIA ASSAY Diagnostic Reagents, Inc. | LEH |
| Nov 5, 1998 | K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS Diagnostic Reagents, Inc. | DKB |
| Sep 12, 1997 | K973102 | LIDOCAINE EIA ASSAY Diagnostic Reagents, Inc. | KLR |
| Aug 28, 1997 | K972835 | 50NG/ML COCAINE METABOLITE CALIBRATOR Diagnostic Reagents, Inc. | DLJ |
| Aug 4, 1997 | K972526 | METHADONE EIA ASSAY Diagnostic Reagents, Inc. | DJR |
| Dec 18, 1996 | K964212 | QUINIDINE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | LBZ |
| Dec 10, 1996 | K963835 | DIGOXIN ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | KXT |
| Aug 14, 1996 | K962463 | PROCAINAMIDE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | LAR |
| Jul 16, 1996 | K961988 | VALPROIC ACID EIA TEST Diagnostic Reagents, Inc. | LEG |
| Jul 8, 1996 | K961373 | ACETAMINOPHEN SERUM TOX EIA ASSAY Diagnostic Reagents, Inc. | LDP |
| Jun 12, 1996 | K961393 | TRICYCLICS SERUM TOX ASSAY Diagnostic Reagents, Inc. | LFH |
| May 20, 1996 | K960708 | BENZODIAZEPINE SERUM TOX EIA TEST Diagnostic Reagents, Inc. | JXM |
| May 15, 1996 | K961273 | AED CALIBRATORS Diagnostic Reagents, Inc. | DKB |
| May 6, 1996 | K960664 | BARBITURATE SERUM TOX EIA ASSAY Diagnostic Reagents, Inc. | DIS |
| May 1, 1996 | K961372 | SERUM TOX CALIBRATOR Diagnostic Reagents, Inc. | DKB |
| Apr 29, 1996 | K961131 | SALICYLATE ASSAY Diagnostic Reagents, Inc. | DKJ |
| Apr 2, 1996 | K960187 | COCAINE METABOLITE EIA TEST Diagnostic Reagents, Inc. | DIO |
| Mar 18, 1996 | K960526 | PRIMIDONE EIA TEST Diagnostic Reagents, Inc. | DJP |
| Mar 11, 1996 | K955928 | BARBITURATE EIA ESSAY (MODIFICATION) Diagnostic Reagents, Inc. | DIS |
| Dec 13, 1995 | K955100 | CARBAMAZEPINE EIA TEST Diagnostic Reagents, Inc. | KLT |
| Oct 20, 1995 | K952178 | PH-DETECT TEST Diagnostic Reagents, Inc. | JQY |
| Aug 11, 1995 | K952596 | THEOPHYLLINE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | KLS |
| Jun 15, 1995 | K951585 | T-UPTAKE CALIBRATORS Diagnostic Reagents, Inc. | JIS |
| May 15, 1995 | K951586 | T-UPTAKE EIA TEST Diagnostic Reagents, Inc. | KHQ |
| Feb 10, 1995 | K946210 | PHENOBARBITAL ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | DLZ |
| Feb 3, 1995 | K945725 | PHENYTION EIA TEST Diagnostic Reagents, Inc. | DIP |
| Jan 17, 1995 | K945338 | THEOPHYLLINE CALIBRATORS Diagnostic Reagents, Inc. | DLJ |
| Jan 4, 1995 | K945316 | PHENOBARBITAL CALIBRATORS Diagnostic Reagents, Inc. | DLJ |
| Dec 9, 1994 | K944703 | THYROXINE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | KLI |
| Dec 7, 1994 | K945337 | PHENYTOIN CALIBRATORS Diagnostic Reagents, Inc. | DLJ |
| Nov 21, 1994 | K944701 | CALIBRATORS Diagnostic Reagents, Inc. | JIS |
| Nov 4, 1994 | K943998 | CANNABINOID EIA ASSAY Diagnostic Reagents, Inc. | LDJ |
| Sep 9, 1994 | K943414 | PROPOXPHENE EIA TEST Diagnostic Reagents, Inc. | JXN |
| Jul 6, 1994 | K940935 | URINE CALIBRATOR Diagnostic Reagents, Inc. | DKB |
| May 3, 1994 | K940123 | METHAQUALONE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | KXS |
| Jan 27, 1994 | K935101 | URINE CALIBRATORS AND CONTROLS MODIFICATION Diagnostic Reagents, Inc. | DKB |
| Jan 26, 1994 | K934667 | METHADONE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | DJR |
| Jan 13, 1994 | K934891 | AMPHETAMINES EIA ASSAY MODIFICATION Diagnostic Reagents, Inc. | DKZ |
| Dec 29, 1993 | K935320 | PHENCYCLIDINE EIA ASSAY Diagnostic Reagents, Inc. | LCM |
| Dec 3, 1993 | K935016 | COCAINE METABOLITE EIA ASSAY MODIFICATION Diagnostic Reagents, Inc. | DIO |
| Aug 23, 1993 | K931780 | METHADONE METABOLITE EIA ASSAY Diagnostic Reagents, Inc. | DJR |
| Aug 5, 1993 | K930529 | BENZODIAZEPINE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | JXM |
| Jul 28, 1993 | K931506 | URINE CALIBRATOR AND CONTROL Diagnostic Reagents, Inc. | DLJ |
| Jun 29, 1993 | K932113 | CANNABINOID URINE CONTROLS Diagnostic Reagents, Inc. | JJX |
| Jan 21, 1993 | K923783 | ETHYL ALCOHOL ASSAY Diagnostic Reagents, Inc. | DMT |
| Dec 30, 1992 | K925491 | BARBITURATE EIA TEST Diagnostic Reagents, Inc. | DIS |
| Dec 9, 1992 | K924733 | ETHYL ALCOHOL CALIBRATORS & CONTROL Diagnostic Reagents, Inc. | DNN |
Newest 50 of 66.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||