Cleared Traditional

S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)

K091413 · Alfa Wassermann, Inc. · Chemistry
Oct 2009
Decision
166d
Days
Class 1
Risk

About This 510(k) Submission

K091413 is an FDA 510(k) clearance for the S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG), a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Alfa Wassermann, Inc. (West Caldwell, US). The FDA issued a Cleared decision on October 26, 2009, 166 days after receiving the submission on May 13, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K091413 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2009
Decision Date October 26, 2009
Days to Decision 166 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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