VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY


Device Classification Name

azo dye, calcium

510(k) Number K072443
Device Name VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek dr.
rochester, 
NY 
14626 -5101

Applicant Contact marlene hanna
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 indigo creek dr.
rochester, 
NY 
14626 -5101

Correspodent Contact marlene hanna
Regulation Number 862.1145
Classification Product Code
CJY  
Subsequent Product Code
JIX  
Date Received 08/30/2007
Decision Date 09/24/2007
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