# Bio-Chem Laboratory Systems, Inc.

- Location (FDA's records): Lakewood, NJ
- FDA decisions: 5 (1992–1995): 5 510(k) clearances
- Product codes: JJE (2), KHO (1), JLW (1), CDX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Diamond Diagnostics, Inc.: 1 (https://510kreport.com/company/diamond-diagnostics)

## Its most-cited devices
- K945271: Atac 8000 Random Access Chemistry System (1995), cited by 1

## Recent decisions
- K945271: Atac 8000 Random Access Chemistry System (Apr 20, 1995)
- K930689: Autobead Thyroid Uptake (Nov 10, 1993)
- K930006: Autobead TSH Enzyme Immunoassay Reagent Kit (Sep 9, 1993)
- K926563: Autobead (TM) T4 Enzyme Immunoassay Test Kit (Mar 18, 1993)
- K924084: Atac 6000 Chemistry Analyzer (Sep 29, 1992)

Source page: https://510kreport.com/company/bio-chem-laboratory-systems