Cleared Traditional

CREATININE

K880629 · Tech-Co, Inc. · Chemistry
Mar 1988
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K880629 is an FDA 510(k) clearance for the CREATININE, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on March 23, 1988, 36 days after receiving the submission on February 16, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K880629 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1988
Decision Date March 23, 1988
Days to Decision 36 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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