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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Natriuretic Peptide
510(k) Number K060632
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Applicant Contact LEAH DE WATER
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Correspondent Contact LEAH DE WATER
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Codes
JIT   JJX  
Date Received03/09/2006
Decision Date 06/06/2006
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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