FDA 510(k) Application Details - K021384

Device Classification Name	Drug Mixture Control Materials   More FDA Info for this Device
510(K) Number	K021384
Device Name	Drug Mixture Control Materials
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	862.3280   More FDA Info for this Regulation Number
Classification Product Code	DIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2002
Decision Date	05/29/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review