Cleared Traditional

SYSTEMATE CREATININE TEST ITEM NUMBER 65413

K932160 · Em Diagnostic Systems, Inc. · Chemistry
Jul 1993
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K932160 is an FDA 510(k) clearance for the SYSTEMATE CREATININE TEST ITEM NUMBER 65413, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on July 9, 1993, 66 days after receiving the submission on May 4, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K932160 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1993
Decision Date July 09, 1993
Days to Decision 66 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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