510(k) K801139

CENTRIFICHEM SYSTEM 500 ANALYZER by Union Carbide Corp. — Product Code JJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1980
Date Received
May 13, 1980
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