FDA 510(k) Application Details - K952666

Device Classification Name	Test, Qualitative And Quantitative Factor Deficiency   More FDA Info for this Device
510(K) Number	K952666
Device Name	Test, Qualitative And Quantitative Factor Deficiency
Applicant	HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 BEAUMONT, TX 77704 US Other 510(k) Applications for this Company
Contact	PAT FRANKS 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	06/12/1995
Decision Date	01/30/1996
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