VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1


definition

Device Classification Name

urease, photometric, urea nitrogen

510(k) Number K001885
Device Name VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Original Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek dr.
rochester, 
NY 
14626 -5101

Original Contact marlene shulman
Regulation Number 862.1770
Classification Product Code
CDN  
Date Received 06/21/2000
Decision Date 07/20/2000
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