Cleared Traditional

LACTATE DEHYDROGENASE REAGENT SYSTEM

K952747 · Medical Diagnostic Technologies, Inc. · Chemistry
Aug 1995
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K952747 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE REAGENT SYSTEM, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on August 7, 1995, 52 days after receiving the submission on June 16, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K952747 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1995
Decision Date August 07, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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