FDA 510(k) Application Details - K002535

Device Classification Name	Controls For Blood-Gases, (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K002535
Device Name	Controls For Blood-Gases, (Assayed And Unassayed)
Applicant	BIO-RAD 9500 JERONIMO RD. IRVINE, CA 92618-2017 US Other 510(k) Applications for this Company
Contact	ELIZABETH PLATT 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	08/16/2000
Decision Date	08/30/2000
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