Cleared Traditional

K940267 - ACE CLINICAL CHEMISTRY SYSTEM
(FDA 510(k) Clearance)

K940267 · Schiapparelli Biosystems, Inc. · Chemistry

May 1994

Decision

102d

Days

Class 2

Risk

K940267 is an FDA 510(k) clearance for the ACE CLINICAL CHEMISTRY SYSTEM, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 3, 1994, 102 days after receiving the submission on January 21, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K940267 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 1994
Decision Date	May 03, 1994
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF