FDA 510(k) Application Details - K051409

Device Classification Name	Stains, Chemical Solution   More FDA Info for this Device
510(K) Number	K051409
Device Name	Stains, Chemical Solution
Applicant	SCANDINAVIAN FORMULAS, INC. 140 EAST CHURCH ST. SELLERSVILLE, PA 18960 US Other 510(k) Applications for this Company
Contact	CATHERINE P PEKLAK Other 510(k) Applications for this Contact
Regulation Number	864.1850   More FDA Info for this Regulation Number
Classification Product Code	LED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2005
Decision Date	08/08/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review