FDA 510(k) Application Details - K955873

Device Classification Name	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)   More FDA Info for this Device
510(K) Number	K955873
Device Name	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Applicant	CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. MEDFIELD, MA 02052-1688 US Other 510(k) Applications for this Company
Contact	STEVEN R RAKITIN 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	12/26/1995
Decision Date	03/11/1996
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