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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, thyroid-stimulating hormone
510(k) Number K081543
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DRIVE
MC881
ROCHESTER,  NY  14626 -5101
Applicant Contact LEAH VAN DE WATER
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DRIVE
MC881
ROCHESTER,  NY  14626 -5101
Correspondent Contact LEAH VAN DE WATER
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Codes
DIP   JIT   JJE  
Date Received06/02/2008
Decision Date 10/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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