Cleared Traditional

IN-VITRO TEST FOR THE DETERMINATION OF CREATININE

K854178 · Clinical Data, Inc. · Chemistry
Nov 1985
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K854178 is an FDA 510(k) clearance for the IN-VITRO TEST FOR THE DETERMINATION OF CREATININE, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on November 25, 1985, 41 days after receiving the submission on October 15, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K854178 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1985
Decision Date November 25, 1985
Days to Decision 41 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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