Cleared Traditional

TRACE MICROPROTEIN REAGENT

K925794 · Trace America, Inc. · Chemistry
Mar 1993
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K925794 is an FDA 510(k) clearance for the TRACE MICROPROTEIN REAGENT, a Turbidimetric, Total Protein (Class II — Special Controls, product code JGQ), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on March 29, 1993, 133 days after receiving the submission on November 16, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K925794 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1992
Decision Date March 29, 1993
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGQ — Turbidimetric, Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635

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