Cleared Traditional

LD-L REAGENT

K971398 · Carolina Liquid Chemistries Corp. · Chemistry
May 1997
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K971398 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 Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on May 2, 1997, 17 days after receiving the submission on April 15, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K971398 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1997
Decision Date May 02, 1997
Days to Decision 17 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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