EASYRA UREA NITROGEN AND CREATININE REAGENTS


Device Classification Name

urease and glutamic dehydrogenase, urea nitrogen

510(k) Number K110675
Device Name EASYRA UREA NITROGEN AND CREATININE REAGENTS
Applicant
MEDICA CORP.
5 oak park drive
bedford, 
MA 
01730

Applicant Contact photios makris
Correspondent
MEDICA CORP.
5 oak park drive
bedford, 
MA 
01730

Correspodent Contact photios makris
Regulation Number 862.1770
Classification Product Code
CDQ  
Subsequent Product Code
CGX  
Date Received 03/10/2011
Decision Date 04/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No