Cleared Traditional

URINE/CSF MICROPROTEIN REAGENT

K913225 · Intersect Systems, Inc. · Chemistry
Oct 1991
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K913225 is an FDA 510(k) clearance for the URINE/CSF MICROPROTEIN REAGENT, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on October 11, 1991, 84 days after receiving the submission on July 19, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K913225 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1991
Decision Date October 11, 1991
Days to Decision 84 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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