# Biotest Diagnostics Corp.

- Location (FDA's records): Denville, NJ
- FDA decisions: 5 (1996–1999): 5 510(k) clearances
- Product codes: LSE (3), LIN (2)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 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
- Gull Laboratories, Inc.: 2 (https://510kreport.com/company/gull-laboratories)
- Incstar Corp.: 1 (https://510kreport.com/company/incstar)

## Firms that cite its devices most
- Intracel Corp.: 1 (https://510kreport.com/company/intracel)

## Its most-cited devices
- K951550: CMV Brite Antigenemia Test Kit (1996), cited by 2

## Recent decisions
- K991650: CMV Brite Turbo Kit (Jul 12, 1999)
- K983841: Biotest Anti-Ebv Recombinant, Ebna Igg (Jun 9, 1999)
- K983839: Biotest Anti-Ebv Recombinant (Jun 9, 1999)
- K983842: Biotest Anti-Ebv Recombinant, EA Igm (Jun 9, 1999)
- K951550: CMV Brite Antigenemia Test Kit (Jan 30, 1996)

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