Cleared Traditional

LD-P REAGENT

K851997 · Alpkem Corp. · Chemistry
May 1985
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K851997 is an FDA 510(k) clearance for the LD-P REAGENT, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on May 30, 1985, 23 days after receiving the submission on May 7, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K851997 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1985
Decision Date May 30, 1985
Days to Decision 23 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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