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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K042406
Device Name OLYMPUS LACTATE, OSR6193
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
JIT  
Date Received09/03/2004
Decision Date 12/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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