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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K032665
Device Name OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
Applicant
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063
Applicant Contact MICHAEL CAMPBELL
Correspondent
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063
Correspondent Contact MICHAEL CAMPBELL
Regulation Number862.1150
Classification Product Code
JIX  
Date Received08/28/2003
Decision Date 11/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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