Cleared Traditional

DUAL VIAL CREATININE REAGENT

K983937 · Intersect Systems, Inc. · Chemistry
Jan 1999
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K983937 is an FDA 510(k) clearance for the DUAL VIAL CREATININE REAGENT, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on January 6, 1999, 62 days after receiving the submission on November 5, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K983937 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1998
Decision Date January 06, 1999
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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