# Hybritech, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 63 (1981–1997): 63 510(k) clearances
- Product codes: JHI (14), JHY (5), JFH (4), JLW (4), CFT (4), JJX (4), DGC (4), DBF (3), CEP (3), CIN (3), GTZ (2), JJQ (2)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Immunodiagnostic Systems, Ltd.: 1 (https://510kreport.com/company/immunodiagnostic-systems)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)

## Its most-cited devices
- K961573: Tandem-R Ostase Immunoradiometric Assay (1996), cited by 2
- K930810: Tandem-R Ostase Immunoradiometric Assay (1994), cited by 1
- K972666: Tandem-MP Ostase Immunoenzymetric Assay (1997), cited by 1

## Recent decisions
- K972666: Tandem-MP Ostase Immunoenzymetric Assay (Sep 11, 1997)
- K961573: Tandem-R Ostase Immunoradiometric Assay (Aug 19, 1996)
- K930810: Tandem-R Ostase Immunoradiometric Assay (Jan 11, 1994)
- K922754: Tandem-E Ige II Calibration Verification Set (Feb 17, 1993)
- K921745: Hybritech Stratus Pap Fluorometric Enzyme Immuno (Jul 30, 1992)
- K920556: Tandem-E HCG Calibration Verification Control Set (Jul 17, 1992)
- K921252: Tandem-E Ferritin Calibration Verification Conrol (Jul 17, 1992)
- K921763: Tandem Icon QSR CKMB Immunoenzymetric Assay (Jun 9, 1992)

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