# Biotech Atlantic, Inc.

- Location (FDA's records): Eatontown, NJ
- FDA decisions: 4 (1994–2003): 4 510(k) clearances
- Product codes: LCX (2), DHA (1), JHI (1)
- Predicates its devices cite: 4 (4 its own); citations of its devices by later devices: 5 (4 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
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)

## Its most-cited devices
- K941090: Unistep HCG Pregnancy Test Strip (1994), cited by 3
- K960174: Unimark Midstream Pregnancy Test Stick (1996), cited by 1
- K032992: Unimark Home Pregnancy Test Device (2003), cited by 1

## Recent decisions
- K032992: Unimark Home Pregnancy Test Device (Nov 21, 2003)
- K013194: Unimark HCG Combo Pregnancy Test (Oct 10, 2001)
- K960174: Unimark Midstream Pregnancy Test Stick (Apr 1, 1996)
- K941090: Unistep HCG Pregnancy Test Strip (Jun 2, 1994)

Source page: https://510kreport.com/company/biotech-atlantic