FDA 510(k) Application Details - K130236

Device Classification Name	Controls For Blood-Gases, (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K130236
Device Name	Controls For Blood-Gases, (Assayed And Unassayed)
Applicant	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ DK-2700 DK Other 510(k) Applications for this Company
Contact	Martin Gabler Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2013
Decision Date	03/15/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review