# Access Bio Incorporate

- Location (FDA's records): North Brunswick, NJ
- FDA decisions: 4 (2003–2005): 4 510(k) clearances
- Product codes: DHA (1), LCX (1), MMI (1), JHI (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
- K051925: Carestart Cardiac 3-in-1 Troponin 1/CK-MB/Myoglobin (Nov 29, 2005)
- K032159: Carestart-Pregnancy and Carestart Plus-Pregnancy (Sep 5, 2003)
- K031048: Carestart HCG Combo One-Step Pregnancy Test and Carestart Plus HCG Combo One-Step Pregnancy Test (Jun 16, 2003)
- K031052: Carestart HCG One-Step Pregnancy Test (Jun 13, 2003)

Source page: https://510kreport.com/company/access-bio-incorporate