Cleared Traditional

ACE CLINICAL CHEMISTRY SYSTEM

K931786 · Schiapparelli Biosystems, Inc. · Chemistry
Sep 1993
Decision
165d
Days
Class 1
Risk

About This 510(k) Submission

K931786 is an FDA 510(k) clearance for the ACE CLINICAL CHEMISTRY SYSTEM, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on September 21, 1993, 165 days after receiving the submission on April 9, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K931786 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1993
Decision Date September 21, 1993
Days to Decision 165 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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