FDA 510(k) Application Details - K955813

Device Classification Name	Calibrators, Drug Specific   More FDA Info for this Device
510(K) Number	K955813
Device Name	Calibrators, Drug Specific
Applicant	MICROGENICS CORP. 2380 A BISSO LN. CONCORD, CA 94520 US Other 510(k) Applications for this Company
Contact	MARY KONING Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DLJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/1995
Decision Date	02/09/1996
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