Cleared Traditional

CREA OR CREATININE

K971908 · Carolina Liquid Chemistries Corp. · Chemistry
Jun 1997
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K971908 is an FDA 510(k) clearance for the CREA OR CREATININE, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 17, 1997, 25 days after receiving the submission on May 23, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K971908 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1997
Decision Date June 17, 1997
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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