510(k) Report

FDA applicant

Alfa Wassermann, Inc.

West Caldwell, NJ9 decisions2007–20131 recall

FDA records 9 decisions for Alfa Wassermann, Inc. (West Caldwell, NJ) from 2007 to 2013: 9 510(k) clearances. Most are in product codes CJE (Nitrophenylphosphate, Alkaline Phosphatase Or…) and KHS (Enzymatic, Carbon-Dioxide). Its devices cite 13 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Alfa Wassermann”.

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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12008: 12009: 32012: 32013: 1
2007high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Alfa Wassermann, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alfa Wassermann, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes1decision
  • KHSEnzymatic, Carbon-Dioxide1decision
  • CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase1decision
  • KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine1decision
  • LCPAssay, Glycosylated Hemoglobin1decision
  • CHHEnzymatic Esterase--Oxidase, Cholesterol1decision

Also: MRR (1), CKA (1), JFY (1).

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K091413S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG)Alfa Wassermann, Inc. · 20092cite it
  • K113382Ace Alt ReagentAlfa Wassermann · 20122cite it
  • K113436Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L ReagentAlfa Wassermann · 20121cites it
  • K113435Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace…Alfa Wassermann · 20121cites it
  • K063306Ace Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C Calibrators, Model S2-72, Hemoglobin A1C Controls…Alfa Wassermann, Inc. · 20071cites it

What has FDA decided for it lately?

  • K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013
  • K113382Ace Alt ReagentAlfa Wassermann · 20121 recall
  • K113436Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L ReagentAlfa Wassermann · 2012
  • K113435Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace…Alfa Wassermann · 2012
  • K091413S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG)Alfa Wassermann, Inc. · 2009
  • K091544S-Test Lactate Dehydrogenase (LD), Model RC 0017Alfa Wassermann, Inc. · 2009
  • K091333S-Test LDL Cholesterol (LDL), Model RC0022Alfa Wassermann, Inc. · 2009
  • K080073S-Test Creatinine (Cre)Alfa Wassermann, Inc. · 2008

All 5 as Alfa Wassermann, Inc. →All 4 as Alfa Wassermann →

What has been recalled?

1 recall linked to its devices; the latest:

  • K113382Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For…Mar 5, 2014Class 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 Diagnostic Technologies, Inc. 23Alfa Biotech (Uk), Ltd. 3Alfa Wassermann Diagnostics Technologies, LLC 3Alfa Tech Medical Systems, Ltd. 2Alfa Technologies, Inc. 1Alfa Thermodiagnostics, Inc. 1Alfa Gate Mazen, Ltd. 1