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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 K011250
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Applicant Contact ANN QUINN
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Correspondent Contact ANN QUINN
Regulation Number862.1660
Classification Product Code
JJX  
Subsequent Product Codes
MJX   MJY  
Date Received04/24/2001
Decision Date 06/13/2001
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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