# Diagnostic Reagents, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 66 (1982–1998): 66 510(k) clearances
- Product codes: DLJ (7), DKB (6), DJR (3), DIO (3), LCM (3), DIS (3), LDJ (2), JXM (2), KXT (2), KHQ (2), JIS (2), CDP (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 37 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Lin-Zhi International, Inc.: 14 (https://510kreport.com/company/lin-zhi-international)
- Schiapparelli Biosystems, Inc.: 8 (https://510kreport.com/company/schiapparelli-biosystems)
- Beckman Instruments, Inc.: 6 (https://510kreport.com/company/beckman-instruments)
- Microgenics Corp.: 5 (https://510kreport.com/company/microgenics)
- Immunalysis Corporation: 3 (https://510kreport.com/company/immunalysis)
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)

## Its most-cited devices
- K983159: Drugs of Abuse Urine Calibrators and Controls (1998), cited by 4
- K931780: Methadone Metabolite Eia Assay (1993), cited by 3
- K943998: Cannabinoid Eia Assay (1994), cited by 2
- K930529: Benzodiazepine Enzyme Immunoassay (1993), cited by 2
- K923783: Ethyl Alcohol Assay (1993), cited by 2
- K935320: Phencyclidine Eia Assay (1993), cited by 2

## Recent decisions
- K983268: Modification of Tricyclic Serum Tox Eia Assay (Nov 18, 1998)
- K983812: Napa Eia Assay (Nov 16, 1998)
- K983323: Digoxin Immunoassay (Nov 12, 1998)
- K983280: Vancomycin Eia Assay (Nov 6, 1998)
- K983159: Drugs of Abuse Urine Calibrators and Controls (Nov 5, 1998)
- K973102: Lidocaine Eia Assay (Sep 12, 1997)
- K972835: 50NG/ML Cocaine Metabolite Calibrator (Aug 28, 1997)
- K972526: Methadone Eia Assay (Aug 4, 1997)

Source page: https://510kreport.com/company/diagnostic-reagents