510(k) K854055

I.C.L.S. COMPULYZER by Integrated Computerized Laboratory Systems, Inc. — Product Code JJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1985
Date Received
October 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class
Class I
Regulation Number
862.2140
Review Panel
CH
Submission Type