# Roche Diagnostic Systems, Inc.

- Location (FDA's records): Montclair, NJ
- FDA decisions: 296 (1983–1999): 296 510(k) clearances
- Product codes: DKZ (17), DIF (14), LAS (14), LDJ (11), DKB (10), DIO (9), JIX (9), DLJ (8), JXM (7), DIS (6), CIT (6), DJG (5)
- Predicates its devices cite: 66 (38 its own); citations of its devices by later devices: 190 (38 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boehringer Mannheim Corp.: 10 (https://510kreport.com/company/boehringer-mannheim)
- Behring Diagnostics, Inc.: 9 (https://510kreport.com/company/behring-diagnostics)
- Abbott Laboratories: 4 (https://510kreport.com/company/abbott-laboratories)
- Reagents Applications, Inc.: 1 (https://510kreport.com/company/reagents-applications)
- Sigma Diagnostics, Inc.: 1 (https://510kreport.com/company/sigma-diagnostics)
- Genzyme Corp.: 1 (https://510kreport.com/company/genzyme)
- Calbiochem-Behring Corp.: 1 (https://510kreport.com/company/calbiochem-behring)
- Eastman Kodak Company: 1 (https://510kreport.com/company/eastman-kodak)

## Firms that cite its devices most
- Roche Diagnostics Corp.: 77 (https://510kreport.com/company/roche-diagnostics)
- Abbott Laboratories: 20 (https://510kreport.com/company/abbott-laboratories)
- Horiba Abx: 19 (https://510kreport.com/company/horiba-abx)
- Stanbio Laboratory: 4 (https://510kreport.com/company/stanbio-laboratory)
- Abaxis, Inc.: 4 (https://510kreport.com/company/abaxis)
- OraSure Technologies, Inc.: 3 (https://510kreport.com/company/orasure-technologies)
- Alfa Wassermann Diagnostic Technologies, Inc.: 3 (https://510kreport.com/company/alfa-wassermann-diagnostic-technologies)
- Osmetech, Inc.: 2 (https://510kreport.com/company/osmetech)

## Its most-cited devices
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes (1995), cited by 32
- K954992: Roche Cobas Integra Reagent Cassettes (1996), cited by 7
- K941837: Roche Reagent for Creatinine (1994), cited by 7
- K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents (1997), cited by 6
- K910591: Roche Reagent for Total Bilirubin (1991), cited by 5
- K883962: Roche Reagent for Inorganic Phosphorus (1988), cited by 4

## Recent decisions
- K983698: Modification to Abuscreen Online Barbiturates (May 3, 1999)
- K983702: Modification to Abuscreen Online for Benzoidiazepines (Feb 11, 1999)
- K983704: Modification to Abuscreen Online for Phencyclidine (Feb 10, 1999)
- K983556: Abuscreen Online Benz 300 Calibrators (Dec 15, 1998)
- K983555: Abuscreen Online Benz 200 Calibrators (Dec 15, 1998)
- K983703: Modification to Abuscreen Online for Methadone (Dec 11, 1998)
- K983700: Modification to Abuscreen Online for Propoxyphene (Dec 11, 1998)
- K983697: Modification to Abuscreen Online Cocaine Metabolite (Dec 11, 1998)

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