FDA 510(k) Application Details - K001891

Device Classification Name	Instrument, Coagulation, Automated   More FDA Info for this Device
510(K) Number	K001891
Device Name	Instrument, Coagulation, Automated
Applicant	BIO/DATA CORP. 155 GIBRALTAR RD. P.O. BOX 347 HORSHAM, PA 19044-0347 US Other 510(k) Applications for this Company
Contact	RODNEY W SCARPELLI 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	06/21/2000
Decision Date	07/12/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review