FDA 510(k) Application Details - K971210

Device Classification Name	Drug Specific Control Materials   More FDA Info for this Device
510(K) Number	K971210
Device Name	Drug Specific Control Materials
Applicant	BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 BREA, CA 92622-8000 US Other 510(k) Applications for this Company
Contact	FRANK MARTE Other 510(k) Applications for this Contact
Regulation Number	862.3280   More FDA Info for this Regulation Number
Classification Product Code	LAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/1997
Decision Date	04/17/1997
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