Cleared Traditional

MICROPROTEIN REAGENT SET

K921412 · Sterling Diagnostics, Inc. · Chemistry
Jan 1993
Decision
303d
Days
Class 2
Risk

About This 510(k) Submission

K921412 is an FDA 510(k) clearance for the MICROPROTEIN REAGENT SET, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on January 21, 1993, 303 days after receiving the submission on March 24, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K921412 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1992
Decision Date January 21, 1993
Days to Decision 303 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CEK — Biuret (colorimetric), Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635

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