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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 K032993
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact SARAH PARSONS
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact SARAH PARSONS
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/25/2003
Decision Date 10/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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