Cleared Traditional

COBAS REAGENT FOR CREATININE

K823573 · Hoffmann-La Roche, Inc. · Chemistry
Jan 1983
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K823573 is an FDA 510(k) clearance for the COBAS REAGENT FOR CREATININE, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983, 32 days after receiving the submission on December 6, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K823573 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1982
Decision Date January 07, 1983
Days to Decision 32 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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