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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 K031031
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact ANN M QUINN
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact ANN M QUINN
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Code
JIT  
Date Received04/01/2003
Decision Date 09/29/2003
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
Recalls CDRH Recalls
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