Cleared Traditional

HICHEM LDH/L REAGENT KIT

K946022 · Hichem Diagnostics · Chemistry
Feb 1995
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K946022 is an FDA 510(k) clearance for the HICHEM LDH/L REAGENT KIT, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on February 23, 1995, 73 days after receiving the submission on December 12, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K946022 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1994
Decision Date February 23, 1995
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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