Cleared Traditional

S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022

K091333 · Alfa Wassermann, Inc. · Chemistry
Aug 2009
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K091333 is an FDA 510(k) clearance for the S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Alfa Wassermann, Inc. (West Caldwell, US). The FDA issued a Cleared decision on August 3, 2009, 89 days after receiving the submission on May 6, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K091333 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2009
Decision Date August 03, 2009
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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