Cleared Traditional

COULTER DART ALT (GPT) REAGENT

K905767 · Coulter Electronics, Inc. · Chemistry
Jan 1991
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K905767 is an FDA 510(k) clearance for the COULTER DART ALT (GPT) REAGENT, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on January 25, 1991, 29 days after receiving the submission on December 27, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K905767 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1990
Decision Date January 25, 1991
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKA — Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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