FDA 510(k) Application Details - K994388

Device Classification Name	Mixture, Control, White-Cell And Red-Cell Indices   More FDA Info for this Device
510(K) Number	K994388
Device Name	Mixture, Control, White-Cell And Red-Cell Indices
Applicant	STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. OMAHA, NE 68145-0625 US Other 510(k) Applications for this Company
Contact	PAUL KITTELSON Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	GLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/1999
Decision Date	01/14/2000
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