Cleared Traditional

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

K950234 · Emd Chemicals, Inc. · Chemistry
Jun 1995
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K950234 is an FDA 510(k) clearance for the TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: 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 June 14, 1995, 152 days after receiving the submission on January 13, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K950234 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1995
Decision Date June 14, 1995
Days to Decision 152 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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