# Alfa Wassermann, Inc.

- Location (FDA's records): West Caldwell, NJ
- FDA decisions: 9 (2007–2013): 9 510(k) clearances
- Names in FDA's records: Alfa Wassermann, Inc. (5); Alfa Wassermann (4)
- Product codes: CJE (1), KHS (1), CFJ (1), KLI (1), LCP (1), CHH (1), MRR (1), CKA (1), JFY (1)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Schiapparelli Biosystems, Inc.: 9 (https://510kreport.com/company/schiapparelli-biosystems)
- Alfa Wassermann Diagnostic Technologies, Inc.: 3 (https://510kreport.com/company/alfa-wassermann-diagnostic-technologies)

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

## Its most-cited devices
- K091413: S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG) (2009), cited by 2
- K113382: Ace Alt Reagent (2012), cited by 2
- K113436: Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L Reagent (2012), cited by 1
- K113435: Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent (2012), cited by 1
- K063306: Ace Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C Calibrators, Model S2-72, Hemoglobin A1C Controls, Model C2-72 (2007), cited by 1

## Recent decisions
- K131515: Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent (Aug 14, 2013)
- K113382: Ace Alt Reagent (Jul 19, 2012)
- K113436: Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L Reagent (Jul 12, 2012)
- K113435: Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent (Jul 2, 2012)
- K091413: S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG) (Oct 26, 2009)
- K091544: S-Test Lactate Dehydrogenase (LD), Model RC 0017 (Sep 9, 2009)
- K091333: S-Test LDL Cholesterol (LDL), Model RC0022 (Aug 3, 2009)
- K080073: S-Test Creatinine (Cre) (Jun 30, 2008)

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