Cleared Traditional

CREATININE (RATE) REAGENT SET

K905619 · Biochemical Trade, Inc. · Chemistry
Feb 1991
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K905619 is an FDA 510(k) clearance for the CREATININE (RATE) REAGENT SET, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on February 13, 1991, 61 days after receiving the submission on December 14, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K905619 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1990
Decision Date February 13, 1991
Days to Decision 61 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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