Cleared Traditional

ACE CLINICAL CHEMISTRY SYSTEM

K941489 · Schiapparelli Biosystems, Inc. · Chemistry
Jul 1994
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K941489 is an FDA 510(k) clearance for the ACE CLINICAL CHEMISTRY SYSTEM, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on July 18, 1994, 112 days after receiving the submission on March 28, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K941489 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1994
Decision Date July 18, 1994
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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