CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL

Device Classification Name

enzymatic, carbon-dioxide

510(k) Number K071340
Device Name CARBON DIOXIDE (CO2), SCAL, NORTROL AND 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 862.1160
Classification Product Code
KHS  
Subsequent Product Codes
JIX   JJY  
Date Received 05/14/2007
Decision Date 10/05/2007
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