Cleared Traditional

BIURET (COLORMETRIC), TOTAL PROTEIN

K901527 · American Research Products Co. · Chemistry
Jul 1990
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K901527 is an FDA 510(k) clearance for the BIURET (COLORMETRIC), TOTAL PROTEIN, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on July 19, 1990, 108 days after receiving the submission on April 2, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K901527 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1990
Decision Date July 19, 1990
Days to Decision 108 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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