# Biogenex Laboratories

- Location (FDA's records): San Ramon, CA
- FDA decisions: 13 (1981–2004): 12 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Biogenex Laboratories (12); Biogenex Laboratories, Inc. (1)
- Product codes: JHI (5), CEP (2), JFH (2), MVC (1), MYA (1), LCX (1), MXZ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dako Corp.: 1 (https://510kreport.com/company/dako)
- Ventana Medical Systems, Inc.: 1 (https://510kreport.com/company/ventana-medical-systems)

## Recent decisions
- P040030: Insite Her-2/Neu Kit (Dec 22, 2004)
- K012960: Biogenex Monoclonal Anti-Progesterone Receptor (Mar 8, 2002)
- K013148: Biogenex Monoclonal Anti-Estrogen Receptor (Clone ER88) (Feb 28, 2002)
- K925189: Pregnagen 1-Step Pregnancy Test (Jan 6, 1993)
- K902208: Modified Ovugen (Jul 17, 1990)
- K884880: Pregnagen (TM) (Jan 13, 1989)
- K882002: Pregnagen (TM) (Sep 9, 1988)
- K873534: Ovugen Suretest (Nov 23, 1987)

Source page: https://510kreport.com/company/biogenex-laboratories