VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3


codes

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 Number 862.1100
Classification Product Code
CIT  
Subsequent Product Codes
CIF   CIQ   CIS  
Date Received 06/01/2000
Decision Date 06/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls