Cleared Traditional

PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM

K051108 · Abaxis, Inc. · Chemistry
Jul 2005
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K051108 is an FDA 510(k) clearance for the PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on July 8, 2005, 67 days after receiving the submission on May 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K051108 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2005
Decision Date July 08, 2005
Days to Decision 67 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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