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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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