Diagnostic Reagents, Inc.
Walker, MI, US
Diagnostic Reagents, Inc. appears in FDA device records in Walker, MI. FDA records list 66 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 66
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 66FDA records hold 66 510(k) clearances for Diagnostic Reagents, Inc. between 1982 and 1998. The busiest year on record is 1996, with 14. The most recent is 1998, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 5 |
| 1991 | 2 |
| 1992 | 11 |
| 1993 | 7 |
| 1994 | 10 |
| 1995 | 9 |
| 1996 | 14 |
| 1997 | 3 |
| 1998 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | LFH | Substantially Equivalent | |
| K983812 | NAPA EIA ASSAY | LAN | Substantially Equivalent | |
| K983323 | DIGOXIN IMMUNOASSAY | KXT | Substantially Equivalent | |
| K983280 | VANCOMYCIN EIA ASSAY | LEH | Substantially Equivalent | |
| K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS | DKB | Substantially Equivalent | |
| K973102 | LIDOCAINE EIA ASSAY | KLR | Substantially Equivalent | |
| K972835 | 50NG/ML COCAINE METABOLITE CALIBRATOR | DLJ | Substantially Equivalent | |
| K972526 | METHADONE EIA ASSAY | DJR | Substantially Equivalent | |
| K964212 | QUINIDINE ENZYME IMMUNOASSAY | LBZ | Substantially Equivalent | |
| K963835 | DIGOXIN ENZYME IMMUNOASSAY | KXT | Substantially Equivalent | |
| K962463 | PROCAINAMIDE ENZYME IMMUNOASSAY | LAR | Substantially Equivalent | |
| K961988 | VALPROIC ACID EIA TEST | LEG | Substantially Equivalent | |
| K961373 | ACETAMINOPHEN SERUM TOX EIA ASSAY | LDP | Substantially Equivalent | |
| K961393 | TRICYCLICS SERUM TOX ASSAY | LFH | Substantially Equivalent | |
| K960708 | BENZODIAZEPINE SERUM TOX EIA TEST | JXM | Substantially Equivalent | |
| K961273 | AED CALIBRATORS | DKB | Substantially Equivalent | |
| K960664 | BARBITURATE SERUM TOX EIA ASSAY | DIS | Substantially Equivalent | |
| K961372 | SERUM TOX CALIBRATOR | DKB | Substantially Equivalent | |
| K961131 | SALICYLATE ASSAY | DKJ | Substantially Equivalent | |
| K960187 | COCAINE METABOLITE EIA TEST | DIO | Substantially Equivalent | |
| K960526 | PRIMIDONE EIA TEST | DJP | Substantially Equivalent | |
| K955928 | BARBITURATE EIA ESSAY (MODIFICATION) | DIS | Substantially Equivalent | |
| K955100 | CARBAMAZEPINE EIA TEST | KLT | Substantially Equivalent | |
| K952178 | PH-DETECT TEST | JQY | Substantially Equivalent | |
| K952596 | THEOPHYLLINE ENZYME IMMUNOASSAY | KLS | Substantially Equivalent | |
| K951585 | T-UPTAKE CALIBRATORS | JIS | Substantially Equivalent | |
| K951586 | T-UPTAKE EIA TEST | KHQ | Substantially Equivalent | |
| K946210 | PHENOBARBITAL ENZYME IMMUNOASSAY | DLZ | Substantially Equivalent | |
| K945725 | PHENYTION EIA TEST | DIP | Substantially Equivalent | |
| K945338 | THEOPHYLLINE CALIBRATORS | DLJ | Substantially Equivalent | |
| K945316 | PHENOBARBITAL CALIBRATORS | DLJ | Substantially Equivalent | |
| K944703 | THYROXINE ENZYME IMMUNOASSAY | KLI | Substantially Equivalent | |
| K945337 | PHENYTOIN CALIBRATORS | DLJ | Substantially Equivalent | |
| K944701 | CALIBRATORS | JIS | Substantially Equivalent | |
| K943998 | CANNABINOID EIA ASSAY | LDJ | Substantially Equivalent | |
| K943414 | PROPOXPHENE EIA TEST | JXN | Substantially Equivalent | |
| K940935 | URINE CALIBRATOR | DKB | Substantially Equivalent | |
| K940123 | METHAQUALONE ENZYME IMMUNOASSAY | KXS | Substantially Equivalent | |
| K935101 | URINE CALIBRATORS AND CONTROLS MODIFICATION | DKB | Substantially Equivalent | |
| K934667 | METHADONE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | |
| K934891 | AMPHETAMINES EIA ASSAY MODIFICATION | DKZ | Substantially Equivalent | |
| K935320 | PHENCYCLIDINE EIA ASSAY | LCM | Substantially Equivalent | |
| K935016 | COCAINE METABOLITE EIA ASSAY MODIFICATION | DIO | Substantially Equivalent | |
| K931780 | METHADONE METABOLITE EIA ASSAY | DJR | Substantially Equivalent | |
| K930529 | BENZODIAZEPINE ENZYME IMMUNOASSAY | JXM | Substantially Equivalent | |
| K931506 | URINE CALIBRATOR AND CONTROL | DLJ | Substantially Equivalent | |
| K932113 | CANNABINOID URINE CONTROLS | JJX | Substantially Equivalent | |
| K923783 | ETHYL ALCOHOL ASSAY | DMT | Substantially Equivalent | |
| K925491 | BARBITURATE EIA TEST | DIS | Substantially Equivalent | |
| K924733 | ETHYL ALCOHOL CALIBRATORS & CONTROL | DNN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JISCalibrator, Primary
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- DNNCalibrators, Ethyl Alcohol
- LDPColorimetry, Acetaminophen
- DKJColorimetry, Salicylate
- DIFDrug Mixture Control Materials
- LASDrug Specific Control Materials
- DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- KLTEnzyme Immunoassay, Carbamazepine
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- KXTEnzyme Immunoassay, Digoxin
- DIPEnzyme Immunoassay, Diphenylhydantoin
- KLREnzyme Immunoassay, Lidocaine
- DJREnzyme Immunoassay, Methadone
- LANEnzyme Immunoassay, N-Acetylprocainamide
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- DLZEnzyme Immunoassay, Phenobarbital
- LAREnzyme Immunoassay, Procainamide
- JXNEnzyme Immunoassay, Propoxyphene
- LBZEnzyme Immunoassay, Quinidine
- KLSEnzyme Immunoassay, Theophylline
- LEGEnzyme Immunoassay, Valproic Acid
- JQYPh Meter
- JJARadio-Labeled Iron Method, Iron (Non-Heme)
- KHQRadioassay, Triiodothyronine Uptake
- DJPRadioimmunoassay, Amphetamine
- KXSRadioimmunoassay, Methaqualone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDPRadioimmunoassay, Total Triiodothyronine
- LEHRadioimmunoassay, Vancomycin
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain