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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
Applicant Contact SARAH PARSONS
Correspondent
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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