Cleared Traditional

TOTAL PROTEIN OR TP

K971524 · Carolina Liquid Chemistries Corp. · Chemistry
May 1997
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K971524 is an FDA 510(k) clearance for the TOTAL PROTEIN OR TP, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on May 16, 1997, 18 days after receiving the submission on April 28, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K971524 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1997
Decision Date May 16, 1997
Days to Decision 18 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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