Cleared Traditional

CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17

K000055 · Diagnostic Chemicals , Ltd. · Chemistry
Feb 2000
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K000055 is an FDA 510(k) clearance for the CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on February 18, 2000, 42 days after receiving the submission on January 7, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K000055 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2000
Decision Date February 18, 2000
Days to Decision 42 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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