Cleared Traditional

LDH-UV REAGENT SET

K821201 · Omega Medical Electronics · Chemistry
Jul 1982
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K821201 is an FDA 510(k) clearance for the LDH-UV REAGENT SET, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982, 84 days after receiving the submission on April 27, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K821201 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1982
Decision Date July 20, 1982
Days to Decision 84 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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