FDA 510(k) Application Details - K990928

Device Classification Name Heavy Metals Control Materials

  More FDA Info for this Device
510(K) Number K990928
Device Name Heavy Metals Control Materials
Applicant BIO-RAD
9500 JERONIMO RD.
IRVINE, CA 92618 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 DIE
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/19/1999
Decision Date 04/16/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact