Cleared Traditional

TOTAL PROTEIN REAGENT CS-724

K833950 · Fisher Scientific Co., LLC · Chemistry
Jan 1984
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K833950 is an FDA 510(k) clearance for the TOTAL PROTEIN REAGENT CS-724, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984, 59 days after receiving the submission on November 15, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K833950 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1983
Decision Date January 13, 1984
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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