• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K121468
Model 179.001.010. 179.002.010, 179.003.010, 183.000.005
Device Name EUROTROL GAS-ISE METABOLITES
Original Applicant
EUROTROL B.V.
keplerlaan 20
ede,  NL 6716 bs
Original Contact paul b.p. kooijmans
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/17/2012
Decision Date 06/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-