FDA 510(k) Application Details - K992199

Device Classification Name	System, Analysis, Electrophoretic Hemoglobin   More FDA Info for this Device
510(K) Number	K992199
Device Name	System, Analysis, Electrophoretic Hemoglobin
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	864.7440   More FDA Info for this Regulation Number
Classification Product Code	JBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/1999
Decision Date	09/21/1999
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