Cleared Traditional

S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017

K091544 · Alfa Wassermann, Inc. · Chemistry
Sep 2009
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K091544 is an FDA 510(k) clearance for the S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Alfa Wassermann, Inc. (West Caldwell, US). The FDA issued a Cleared decision on September 9, 2009, 105 days after receiving the submission on May 27, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K091544 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2009
Decision Date September 09, 2009
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFJ — Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1440

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