# Direct Access Diagnostics

- Location (FDA's records): Bridgewater, NJ
- FDA decisions: 2 (1996–1996): 2 510(k) clearances
- Product codes: LCX (2)
- Predicates its devices cite: 0 (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 that cite its devices most
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)

## Its most-cited devices
- K962521: Factplus One Step Pregnancy Test (1996), cited by 1

## Recent decisions
- K964108: Fact Plus Pregnancy Test (Nov 18, 1996)
- K962521: Factplus One Step Pregnancy Test (Jul 29, 1996)

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