# Alfa Wassermann Diagnostics Technologies, LLC

- Location (FDA's records): West Caldwell, NJ
- FDA decisions: 3 (2012–2013): 3 510(k) clearances
- Product codes: CIX (1), CDN (1), JGJ (1)
- Predicates its devices cite: 5 (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
- Schiapparelli Biosystems, Inc.: 2 (https://510kreport.com/company/schiapparelli-biosystems)
- Alfa Wassermann Diagnostic Technologies, Inc.: 2 (https://510kreport.com/company/alfa-wassermann-diagnostic-technologies)
- Alfa Wassermann, Inc.: 1 (https://510kreport.com/company/alfa-wassermann)

## Recent decisions
- K131488: Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace Phosphorus Reagent (Aug 19, 2013)
- K123322: Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK Reagent (May 21, 2013)
- K122302: Ace Magnesium Regent (Aug 27, 2012)

Source page: https://510kreport.com/company/alfa-wassermann-diagnostics-technologies