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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3, Antigen, Antiserum, Control
510(k) Number K962409
Device Name OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
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 Number866.5240
Classification Product Code
CZW  
Date Received06/21/1996
Decision Date 10/18/1996
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
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