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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, serological, positive control
510(k) Number K030067
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
Applicant
ORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact SARAH PARSONS
Correspondent
ORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact SARAH PARSONS
Regulation Number862.1660
Classification Product Code
MJX  
Date Received01/07/2003
Decision Date 01/17/2003
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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