FDA 510(k) Application Details - K993553

Device Classification Name	Test, Qualitative And Quantitative Factor Deficiency   More FDA Info for this Device
510(K) Number	K993553
Device Name	Test, Qualitative And Quantitative Factor Deficiency
Applicant	GENETIC TESTING INSTITUTE 150 NORTH PATRICK BLVD. SUITE 100 BROOKFIELD, WI 53045-5854 US Other 510(k) Applications for this Company
Contact	MICHAEL MOGHADDAM 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	10/20/1999
Decision Date	02/01/2000
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