Cleared Traditional

TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2

K950128 · Emd Chemicals, Inc. · Chemistry
May 1995
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K950128 is an FDA 510(k) clearance for the TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on May 15, 1995, 123 days after receiving the submission on January 12, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K950128 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1995
Decision Date May 15, 1995
Days to Decision 123 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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