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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K990061
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14650 -0882
Applicant Contact ANNE ZAVERTNIK
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14650 -0882
Correspondent Contact ANNE ZAVERTNIK
Regulation Number862.1660
Classification Product Code
JJX  
Date Received01/08/1999
Decision Date 01/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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