FDA 510(k) Application Details - K023362

Device Classification Name	Instrument, Coagulation, Automated   More FDA Info for this Device
510(K) Number	K023362
Device Name	Instrument, Coagulation, Automated
Applicant	FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645-0307 US Other 510(k) Applications for this Company
Contact	JERALD STEINER Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	GKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2002
Decision Date	12/09/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review