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510(k) K003721

MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER by Olympus America, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2000
Date Received
December 4, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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