S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)— 510(k) K091413

Name: FDA 510(k) clearance K091413
Creator: U.S. Food and Drug Administration
Published: 2009-10-26

Substantially Equivalent

Alfa Wassermann, Inc.

FDA 510(k) clearance K091413 for S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG), Substantially Equivalent on 2009-10-26. Applicant: Alfa Wassermann, Inc.. Device class: 1.

Clearance details

Applicant: Alfa Wassermann, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2009-05-13
Decision date: 2009-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

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