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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nadh oxidation/nad reduction, ast/sgot
510(k) Number K001679
Device Name VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
Original Applicant
ORTHO-CLINICAL DIAGNOSTICS, INC.
100 indigo creek dr.
rochester,  NY  14626 5101
Original Contact marlene a shulman
Regulation Number862.1100
Classification Product Code
CIT  
Subsequent Product Codes
CIF   CIQ   CIS  
Date Received06/01/2000
Decision Date 06/28/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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