Cleared Traditional

LACTATE DEHYDROGENASE (LD)

K970684 · Randox Laboratories, Ltd. · Chemistry
May 1997
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K970684 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE (LD), a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on May 7, 1997, 72 days after receiving the submission on February 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K970684 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1997
Decision Date May 07, 1997
Days to Decision 72 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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