EUROTROL GAS-ISE METABOLITES


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K121468
Device Name EUROTROL GAS-ISE METABOLITES
Applicant
EUROTROL B.V.
keplerlaan 20
ede, 

NL

6716 bs

Applicant Contact paul b.p. kooijmans
Correspondent
EUROTROL B.V.
keplerlaan 20
ede, 

NL

6716 bs

Correspodent Contact paul b.p. kooijmans
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 05/17/2012
Decision Date 06/22/2012
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