# Biostar, Inc.

- Location (FDA's records): Boulder, CO
- FDA decisions: 6 (1994–1999): 6 510(k) clearances
- Product codes: GTY (2), GTZ (1), LLH (1), LJC (1), PSZ (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Meridian Diagnostics, Inc.: 1 (https://510kreport.com/company/meridian-diagnostics)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Thermo Biostar, Inc.: 3 (https://510kreport.com/company/thermo-biostar)
- Infectio Diagnostic, Inc.: 1 (https://510kreport.com/company/infectio-diagnostic)

## Its most-cited devices
- K981651: AB Flu Oia (1998), cited by 2
- K991828: Strep B Oia (1999), cited by 1
- K936112: Strep B Oia (1994), cited by 1
- K951010: Chlamydia Oia (1995), cited by 1

## Recent decisions
- K991829: Cdtox a Oia (Nov 2, 1999)
- K991828: Strep B Oia (Aug 19, 1999)
- K981651: AB Flu Oia (Nov 25, 1998)
- K962060: Strep a Oia Max (Jul 23, 1997)
- K951010: Chlamydia Oia (Oct 7, 1995)
- K936112: Strep B Oia (Jul 6, 1994)

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