FDA 510(k) Application Details - K111356

Device Classification Name	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica   More FDA Info for this Device
510(K) Number	K111356
Device Name	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Applicant	ARLINGTON SCIENTIFIC, INC. 1840 NORTH TECHNOLOGY DR. SPRINGVILLE, UT 84663 US Other 510(k) Applications for this Company
Contact	DAVID BINKS Other 510(k) Applications for this Contact
Regulation Number	862.2400   More FDA Info for this Regulation Number
Classification Product Code	JQT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2011
Decision Date	11/09/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review