Cleared Traditional

LACTATE DEHYDROGENASE LDH

K883206 · Electro-Nucleonics, Inc. · Chemistry
Sep 1988
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K883206 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE LDH, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 9, 1988, 43 days after receiving the submission on July 28, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K883206 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1988
Decision Date September 09, 1988
Days to Decision 43 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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