# Biosafe Laboratories, Inc.

- Location (FDA's records): Lake Forest, IL
- FDA decisions: 6 (1999–2004): 6 510(k) clearances
- Product codes: JLW (2), LCP (1), CHH (1), JKA (1), KHG (1)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 2 (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
- Beckman-Diagnostic Systems Group: 2 (https://510kreport.com/company/beckman-diagnostic-systems-group)
- Sigma Diagnostics, Inc.: 2 (https://510kreport.com/company/sigma-diagnostics)
- Beckman Instruments, Inc.: 2 (https://510kreport.com/company/beckman-instruments)
- Flexsite Diagnostics, Inc.: 1 (https://510kreport.com/company/flexsite-diagnostics)

## Firms that cite its devices most
- Sanguina, Inc.: 1 (https://510kreport.com/company/sanguina)
- Home Access Health Corp.: 1 (https://510kreport.com/company/home-access-health)

## Its most-cited devices
- K012221: Safe at Home Cholesterol Profile Blood Collection and Transport System (2002), cited by 1
- K042379: Anemiapro Self-Screener (2004), cited by 1

## Recent decisions
- K042379: Anemiapro Self-Screener (Dec 15, 2004)
- K012221: Safe at Home Cholesterol Profile Blood Collection and Transport System (Apr 3, 2002)
- K011970: Biosafe Cholesterol Profile Blood Collection and Transport System (Sep 26, 2001)
- K011525: Safe at Home TSH (Thyroid Stimulating Hormone Blood Collection and Transport System) (Jul 16, 2001)
- K003752: Biosafe Capillary Blood Transport System for Testing Thyroid Stimulating Hormone (TSH) (Mar 23, 2001)
- K991850: Safe at-Home Test Kit for Monitoring Hemoglobin Alc (Nov 26, 1999)

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