Medical Device Manufacturer · US , West Caldwell , NJ

Alfa Wassermann, Inc.

5 submissions · 5 cleared · Since 2007
5
Total
5
Cleared
0
Denied

Alfa Wassermann, Inc. — FDA 510(k) Submissions

Alfa Wassermann, Inc. has submitted 5 FDA 510(k) premarket notifications since 2007, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assay, Glycosylated Hemoglobin, Enzymatic Method, Creatinine, System, Test, Low Density, Lipoprotein, Enzymatic Esterase--oxidase, Cholesterol, Nad Reduction/nadh Oxidation, Lactate Dehydrogenase . Use the specialty filter in the sidebar to narrow results.

5 devices
1–5 of 5
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
K091413 · CHH Enzymatic... · Chemistry
Oct 2009 166d
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
K091544 · CFJ Nad Reduction/nadh... · Chemistry
Sep 2009 105d
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
K091333 · MRR System, Test, Low... · Chemistry
Aug 2009 89d
S-TEST CREATININE (CRE)
K080073 · JFY Enzymatic Method, Creatinine · Chemistry
Jun 2008 171d
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
K063306 · LCP Assay, Glycosylated... · Chemistry
Apr 2007 167d
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