# Access Bio, Inc.

- Location (FDA's records): Somerset, NJ
- FDA decisions: 3 (2020–2025): 3 510(k) clearances
- Product codes: QYT (1), PSZ (1), SCA (1)
- Predicates its devices cite: 3 (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
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Bd: 1 (https://510kreport.com/company/bd)
- Wondfo USA Co, Ltd.: 1 (https://510kreport.com/company/wondfo-usa)

## Firms that cite its devices most
- Innovita (Tangshan) Biological Technology Co., Ltd.: 1 (https://510kreport.com/company/innovita-tangshan-biological-technology)

## Its most-cited devices
- K191514: CareStart Flu A&B Plus (2020), cited by 1

## Recent decisions
- K251604: CareSuperb COVID-19/Flu A&B Antigen Combo Home Test (Aug 22, 2025)
- K241915: CareSuperb™ COVID-19 Antigen Home Test (Jan 29, 2025)
- K191514: CareStart Flu A&B Plus (Feb 18, 2020)

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