UREA/BUN, SCAL, NORTROL, ABTROL


Device Classification Name

urease and glutamic dehydrogenase, urea nitrogen

510(k) Number K073295
Device Name UREA/BUN, SCAL, NORTROL, ABTROL
Applicant
THERMO FISHER SCIENTIFIC OY
2 ratastie
vantaa, 

FI

01620

Applicant Contact paivi sormunen
Correspondent
THERMO FISHER SCIENTIFIC OY
2 ratastie
vantaa, 

FI

01620

Correspodent Contact paivi sormunen
Regulation Number 862.1770
Classification Product Code
CDQ  
Subsequent Product Codes
JIX   JJY  
Date Received 11/23/2007
Decision Date 05/29/2008
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