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510(k) K043460

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 by Olympus America, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2005
Date Received
December 15, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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