FDA 510(k) Application Details - K012656

Device Classification Name	Enzyme Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K012656
Device Name	Enzyme Controls (Assayed And Unassayed)
Applicant	BIO-RAD 9500 JERONIMO RD. IRVINE, CA 92618-2017 US Other 510(k) Applications for this Company
Contact	MARIA ZEBALLOS Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2001
Decision Date	09/06/2001
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