Cleared Traditional

CREATININE RATE REAGENT KIT

K811406 · Chem-Elec, Inc. · Chemistry
Aug 1981
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K811406 is an FDA 510(k) clearance for the CREATININE RATE REAGENT KIT, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Chem-Elec, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 86 days after receiving the submission on May 19, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K811406 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1981
Decision Date August 13, 1981
Days to Decision 86 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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