VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2


Device Classification Name

electrode, ion specific, sodium

510(k) Number K081411
Device Name VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek dr.
rochester, 
NY 
14626 -5101

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

Correspodent Contact marlene a hanna
Regulation Number 862.1665
Classification Product Code
JGS  
Subsequent Product Code
JJX  
Date Received 05/20/2008
Decision Date 06/30/2008
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

Recalls CDRH Recalls