FDA 510(k) Application Details - K101911

Device Classification Name	Assay, Proliferation, In Vitro, T Lymphocyte   More FDA Info for this Device
510(K) Number	K101911
Device Name	Assay, Proliferation, In Vitro, T Lymphocyte
Applicant	CYLEX, INC. P.O. BOX 103 BALDWIN, MD 21013 US Other 510(k) Applications for this Company
Contact	Judi Smith Other 510(k) Applications for this Contact
Regulation Number	864.5220   More FDA Info for this Regulation Number
Classification Product Code	NID Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2010
Decision Date	10/18/2010
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