FDA 510(k) Application Details - K961355

Device Classification Name	Controls For Blood-Gases, (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K961355
Device Name	Controls For Blood-Gases, (Assayed And Unassayed)
Applicant	RADIOMETER AMERICA, INC. 811 SHARON DR. WESTLAKE, OH 44145-1598 US Other 510(k) Applications for this Company
Contact	DONALD L BAKER 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	04/08/1996
Decision Date	06/14/1996
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