# Universal Reagents, Inc.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 8 (1996–1997): 8 510(k) clearances
- Product codes: GGP (5), GJT (3)
- Predicates its devices cite: 15 (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

## Firms whose devices it cites most
- Medical Diagnostic Technologies, Inc.: 8 (https://510kreport.com/company/medical-diagnostic-technologies)
- Behring Diagnostics, Inc.: 3 (https://510kreport.com/company/behring-diagnostics)
- Sigma Chemical Co.: 1 (https://510kreport.com/company/sigma-chemical)
- General Diagnostics: 1 (https://510kreport.com/company/general-diagnostics)
- Ortho Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/ortho-diagnostic-systems)
- Helena Laboratories: 1 (https://510kreport.com/company/helena-laboratories)

## Recent decisions
- K973143: Universal Reagent Factor Xii (Twelve) Deficient Plasma (Sep 25, 1997)
- K972288: Factor Deficient Plasmas - Factor IX (9) (Jul 14, 1997)
- K972286: Factor Deficient Plasmas - Factor XI (11) (Jul 14, 1997)
- K970593: Universal Reagent Factor Viii Deficient Plasma (Apr 25, 1997)
- K970607: Universal Reagent Factor Vii Deficient Plasma (Apr 25, 1997)
- K964459: Universal Reagent Factor X Deficient Plasma (Dec 18, 1996)
- K964270: Universal Reagent Factor V Deficient Plasma (Dec 18, 1996)
- K961929: Factor Deficient Plasma (Oct 10, 1996)

Source page: https://510kreport.com/company/universal-reagents