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510(k) K001679

VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 by Ortho-Clinical Diagnostics, Inc. — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2000
Date Received
June 1, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
Review Panel
CH
Submission Type

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