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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antistreptolysin - Titer/Streptolysin O Reagent
510(k) Number K052645
Device Name VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
Applicant
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626
Applicant Contact MICHAEL M BYRNE
Correspondent
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626
Correspondent Contact MICHAEL M BYRNE
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received09/26/2005
Decision Date 12/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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