VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2


Device Classification Name

electrode, ion specific, potassium

510(k) Number K073157
Device Name VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
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 862.1600
Classification Product Code
CEM  
Subsequent Product Code
JIX  
Date Received 11/08/2007
Decision Date 12/07/2007
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