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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 K003112
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Applicant Contact SUSAN WERNER
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Correspondent Contact SUSAN WERNER
Regulation Number862.1660
Classification Product Code
JJX  
Subsequent Product Codes
MJX   MJY  
Date Received10/04/2000
Decision Date 11/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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