FDA 510(k) Application Details - K013316

Device Classification Name	Test, Sickle Cell   More FDA Info for this Device
510(K) Number	K013316
Device Name	Test, Sickle Cell
Applicant	STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. LA VISTA, NE 68128 US Other 510(k) Applications for this Company
Contact	PAUL KITTELSON Other 510(k) Applications for this Contact
Regulation Number	864.7825   More FDA Info for this Regulation Number
Classification Product Code	GHM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2001
Decision Date	11/06/2001
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