# Alfa Wassermann Diagnostic Technologies, Inc.

- Location (FDA's records): West Caldwell, NJ
- FDA decisions: 23 (2008–2018): 23 510(k) clearances
- Names in FDA's records: Alfa Wassermann Diagnostic Technologies, Inc. (21); Alfa Wassermann Diagnostic Technologies, LLC (2)
- Product codes: CHH (3), LCP (3), KHS (2), CDN (2), CIX (2), CFR (2), CJE (1), JHS (1), CKF (1), CFJ (1), DCN (1), JMO (1)
- Predicates its devices cite: 58 (3 its own); citations of its devices by later devices: 9 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Schiapparelli Biosystems, Inc.: 29 (https://510kreport.com/company/schiapparelli-biosystems)
- Abaxis, Inc.: 6 (https://510kreport.com/company/abaxis)
- Olympus America, Inc.: 5 (https://510kreport.com/company/olympus-america)
- Alfa Wassermann, Inc.: 3 (https://510kreport.com/company/alfa-wassermann)
- Roche Diagnostic Systems, Inc.: 3 (https://510kreport.com/company/roche-diagnostic-systems)
- Clinical Diagnostic Systems, Inc.: 2 (https://510kreport.com/company/clinical-diagnostic-systems)
- Heraeus Kulzer, Inc.: 2 (https://510kreport.com/company/heraeus-kulzer)
- Technicon Instruments Corp.: 1 (https://510kreport.com/company/technicon-instruments)

## Firms that cite its devices most
- Alfa Wassermann, Inc.: 3 (https://510kreport.com/company/alfa-wassermann)
- Alfa Wassermann Diagnostics Technologies, LLC: 2 (https://510kreport.com/company/alfa-wassermann-diagnostics-technologies)
- Hitachi Chemical Diagnostics, Inc.: 1 (https://510kreport.com/company/hitachi-chemical-diagnostics)

## Its most-cited devices
- K113253: Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace Bun/Ureanitrogen Reagent (2012), cited by 4
- K113374: Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace Phosphorus U.V. Reagent (2012), cited by 1
- K113262: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides Reagent (2012), cited by 1
- K113438: Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent (2012), cited by 1
- K072140: S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test Glu (2008), cited by 1
- K113437: Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent (2012), cited by 1

## Recent decisions
- K170623: ACE Hemoglobin A1c (HbA1c) Reagent (Feb 27, 2018)
- K131975: Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L Reagent (Oct 2, 2013)
- K131351: Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast Reagent (Aug 15, 2013)
- K123953: Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent (May 2, 2013)
- K123018: Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) Module (Apr 23, 2013)
- K122757: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides Reagent (Oct 5, 2012)
- K113389: Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine Reagent (Aug 10, 2012)
- K113437: Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent (Aug 6, 2012)

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