510(k) Report

FDA applicant

Alfa Wassermann Diagnostic Technologies, Inc.

West Caldwell, NJ23 decisions2008–20182 recalls

FDA records 23 decisions for Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, NJ) from 2008 to 2018: 23 510(k) clearances. Most are in product codes CHH (Enzymatic Esterase--Oxidase, Cholesterol) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 58 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Alfa Wassermann Diagnostic Technologies, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Alfa Wassermann Diagnostic Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2008: 72009: 22011: 12012: 82013: 42018: 1
2008high 8 (2012) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2014

2012: 12014: 1
2008high 1 (2012) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Alfa Wassermann Diagnostic Technologies, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CHHEnzymatic Esterase--Oxidase, Cholesterol3decisions
  • LCPAssay, Glycosylated Hemoglobin3decisions
  • KHSEnzymatic, Carbon-Dioxide2decisions
  • CDNUrease, Photometric, Urea Nitrogen2decisions
  • CIXBromcresol Green Dye-Binding, Albumin2decisions
  • CFRHexokinase, Glucose2decisions

Also: CJE (1), JHS (1), CKF (1), CFJ (1), DCN (1), JMO (1).

Whose devices does it build on?

Its devices cite 58 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113253Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace Bun/Ureanitrogen ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 20124cite it
  • K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace Phosphorus U.V. ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 20121cites it
  • K113262Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 20121cites it
  • K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 20121cites it
  • K072140S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc. · 20081cites it
  • K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 20121cites it

What has FDA decided for it lately?

  • K170623ACE Hemoglobin A1c (HbA1c) ReagentAlfa Wassermann Diagnostic Technologies, LLC · 2018
  • K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC · 20131 recall
  • K123953Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) ModuleAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • K113389Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012

All 21 as Alfa Wassermann Diagnostic Technologies, Inc. →All 2 as Alfa Wassermann Diagnostic Technologies, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K131351Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For…Mar 5, 2014Class II
  • K103615Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic…Oct 10, 2012Class II

Other applicant names beginning “Alfa”

FDA records each applicant name separately; these may or may not be the same firm.

Alfa Scientific Designs, Inc. 44Alfa Wassermann, Inc. 9Alfa Biotech (Uk), Ltd. 3Alfa Wassermann Diagnostics Technologies, LLC 3Alfa Tech Medical Systems, Ltd. 2Alfa Technologies, Inc. 1Alfa Thermodiagnostics, Inc. 1Alfa Gate Mazen, Ltd. 1