# Biotrack, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 16 (1986–1993): 16 510(k) clearances
- Product codes: JJQ (3), DIP (1), GJS (1), KLT (1), LAW (1), KHG (1), GFO (1), CJJ (1), GIT (1), DIF (1), KLS (1), DIS (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Roche Diagnostics/Boehringer Mannheim GmbH: 3 (https://510kreport.com/company/roche-diagnostics-boehringer-mannheim)

## Its most-cited devices
- K890052: Biotrack Aptt Reagent Cartridge (1989), cited by 1
- K890051: Biotrack Aptt Controls (1989), cited by 1
- K860720: Biotrack Monitor (Biotrack Reagent Cartridges) (1986), cited by 1

## Recent decisions
- K934062: Biotrack Therapeutic Drug-Monitoring Qual Controls (Dec 29, 1993)
- K934061: Biotrack Valproic Acid Test Cartridge (Dec 29, 1993)
- K920525: Biotrack Therapeutic Drug Monitoring Qual. Control (Aug 5, 1992)
- K915755: Biotrack Phenytoin Test Cartridge (Jul 23, 1992)
- K915756: Biotrack Carbamazepine Test Cartridge (Jul 23, 1992)
- K903924: Biotrack Theophylline Quality Controls (Sep 17, 1990)
- K900373: Biotrack Theophylline Test Cartridge (May 30, 1990)
- K900372: Biotrack Immunochemistry Monitor (Feb 23, 1990)

Source page: https://510kreport.com/company/biotrack