Cleared Traditional

TOTAL PROTEIN REAGENT

K955936 · Derma Media Lab., Inc. · Chemistry
Mar 1996
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K955936 is an FDA 510(k) clearance for the TOTAL PROTEIN REAGENT, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on March 12, 1996, 82 days after receiving the submission on December 21, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K955936 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1995
Decision Date March 12, 1996
Days to Decision 82 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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