FDA 510(k) Application Details - K955562

Device Classification Name	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)   More FDA Info for this Device
510(K) Number	K955562
Device Name	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Applicant	OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317 PORTLAND, OR 97217-3935 US Other 510(k) Applications for this Company
Contact	LYNDA M TAYLOR Other 510(k) Applications for this Contact
Regulation Number	862.3350   More FDA Info for this Regulation Number
Classification Product Code	LGR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/1995
Decision Date	01/24/1996
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