Cleared Traditional

CREATININE

K850932 · Dilab, Inc. · Chemistry
Jun 1985
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K850932 is an FDA 510(k) clearance for the CREATININE, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 25, 1985, 110 days after receiving the submission on March 7, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K850932 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1985
Decision Date June 25, 1985
Days to Decision 110 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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