Cleared Traditional

COULTER LD (LDH-L) REAGENT

K897164 · Coulter Electronics, Inc. · Chemistry
Mar 1990
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K897164 is an FDA 510(k) clearance for the COULTER LD (LDH-L) REAGENT, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on March 9, 1990, 71 days after receiving the submission on December 28, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K897164 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1989
Decision Date March 09, 1990
Days to Decision 71 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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