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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K062838
Device Name VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
Applicant
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Applicant Contact CHARLOTTE BAKER
Correspondent
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Correspondent Contact CHARLOTTE BAKER
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Codes
JIT   JJX  
Date Received09/21/2006
Decision Date 12/19/2006
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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