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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 K992366
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact MARLENE A SHULMAN
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact MARLENE A SHULMAN
Regulation Number862.1215
Classification Product Code
MMI  
Date Received07/15/1999
Decision Date 10/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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