# Biochem Immunosystems (U.S.), Inc.

- Location (FDA's records): Allentown, PA
- FDA decisions: 4 (1996–1997): 4 510(k) clearances
- Product codes: JHI (1), CDZ (1), GKZ (1), JJE (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Serono Baker Diagnostics System: 1 (https://510kreport.com/company/serono-baker-diagnostics-system)

## Firms that cite its devices most
- Techlab, Inc.: 1 (https://510kreport.com/company/techlab)

## Its most-cited devices
- K971761: Personallab Automated Microplate Analyzer (1997), cited by 1

## Recent decisions
- K971761: Personallab Automated Microplate Analyzer (Jul 22, 1997)
- K960072: Spirit Hematology System Model LE, CP, & AX (Mar 6, 1997)
- K954065: Biodata SR1 Fah-HCG Enzyme Immunoassay Kit (Jul 10, 1996)
- K955102: Biodata Testosterone Maia Kit (Jun 24, 1996)

Source page: https://510kreport.com/company/biochem-immunosystems-us