Cleared Traditional

K930104 - ACE CLINICAL CHEMISTRY SYSTEM
(FDA 510(k) Clearance)

K930104 · Schiapparelli Biosystems, Inc. · Chemistry

Aug 1993

Decision

224d

Days

Class 2

Risk

K930104 is an FDA 510(k) clearance for the ACE CLINICAL CHEMISTRY SYSTEM, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on August 23, 1993, 224 days after receiving the submission on January 11, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K930104 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 1993
Decision Date	August 23, 1993
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement