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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K063720
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
Applicant
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Applicant Contact SARAH CV PARSONS
Correspondent
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Correspondent Contact SARAH CV PARSONS
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Codes
JIT   JJX  
Date Received12/15/2006
Decision Date 04/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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