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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transferrin, Rhodamine, Antigen, Antiserum, Control
510(k) Number K963139
Device Name OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number866.5880
Classification Product Code
DDD  
Date Received08/12/1996
Decision Date 02/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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