FDA 510(k) Application Details - K961441

Device Classification Name	Controls For Blood-Gases, (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K961441
Device Name	Controls For Blood-Gases, (Assayed And Unassayed)
Applicant	INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. TEWKSBURY, MA 01876 US Other 510(k) Applications for this Company
Contact	JOEL C KENT 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	04/15/1996
Decision Date	04/30/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review