FDA 510(k) Application Details - K000398

Device Classification Name	Test, Qualitative And Quantitative Factor Deficiency   More FDA Info for this Device
510(K) Number	K000398
Device Name	Test, Qualitative And Quantitative Factor Deficiency
Applicant	SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE DD2 1SW GB Other 510(k) Applications for this Company
Contact	EILEEN MCCAFFERTY Other 510(k) Applications for this Contact
Regulation Number	864.7290   More FDA Info for this Regulation Number
Classification Product Code	GGP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2000
Decision Date	04/17/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review