# Pacific Biotech, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 29 (1983–1993): 29 510(k) clearances
- Product codes: JHI (13), GTZ (3), JLW (3), LCX (2), KTN (2), CGJ (1), DHA (1), JHJ (1), GTY (1), CEP (1), CFT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K924461: Strep a Negative Control (Dec 2, 1993)
- K902510: Cards O.S. Mono (Jul 16, 1990)
- K896482: Perfect (TM) One Step Early Pregnancy Test Kit (Mar 6, 1990)
- K896221: Cards O.S.(TM) Strep a (Dec 13, 1989)
- K895390: Cards O.S. (TM) HCG-Urine (Nov 13, 1989)
- K891770: HCG Irma II (May 24, 1989)
- K884616: Firstday Early Pregnancy Testing Kit II (Jan 13, 1989)
- K883742: Modified TSH Irma Kit (Jan 3, 1989)

Source page: https://510kreport.com/company/pacific-biotech