510(k) K920942

OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER by Olympus Corp. — Product Code JJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1992
Date Received
February 27, 1992
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