Cleared Traditional

TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50

K973108 · Diagnostic Chemicals , Ltd. · Chemistry
Mar 1998
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K973108 is an FDA 510(k) clearance for the TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on March 2, 1998, 195 days after receiving the submission on August 19, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K973108 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1997
Decision Date March 02, 1998
Days to Decision 195 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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