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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact PAUL B.P. KOOIJMANS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/17/2012
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
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