Cleared Traditional

AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791

K900666 · American Research Products Co. · Chemistry
Apr 1990
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K900666 is an FDA 510(k) clearance for the AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on April 19, 1990, 65 days after receiving the submission on February 13, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K900666 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1990
Decision Date April 19, 1990
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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