Cleared Traditional

ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET

K871781 · Biochemical Trade, Inc. · Chemistry
Jun 1987
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K871781 is an FDA 510(k) clearance for the ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on June 3, 1987, 28 days after receiving the submission on May 6, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K871781 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1987
Decision Date June 03, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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