VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4


Device Classification Name

bromcresol green dye-binding, albumin

510(k) Number K023875
Device Name VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
Original Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek dr.
rochester, 
NY 
14626 -5101

Original Contact marlene a hanna
Regulation Number 862.1035
Classification Product Code
CIX  
Subsequent Product Code
JIX  
Date Received 11/21/2002
Decision Date 12/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls