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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 K043460
Device Name OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
Applicant
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Applicant Contact BEV HARDING
Correspondent
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Correspondent Contact BEV HARDING
Regulation Number862.1150
Classification Product Code
JIX  
Date Received12/15/2004
Decision Date 01/31/2005
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
Recalls CDRH Recalls
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