VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

Device Classification Name

enzymatic method, creatinine

510(k) Number K001310
Device Name VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Original Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek dr.
rochester, 
NY 
14626 -5101

Original Contact marlene a shulman
Regulation Number 862.1225
Classification Product Code
JFY  
Subsequent Product Code
JIX  
Date Received 04/25/2000
Decision Date 05/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Special
Reviewed by Third Party No

Combination Product

No