Cleared Traditional

LD-L REAGENT

K851996 · Alpkem Corp. · Chemistry
May 1985
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K851996 is an FDA 510(k) clearance for the LD-L 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 31, 1985, 24 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 K851996 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1985
Decision Date May 31, 1985
Days to Decision 24 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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