FDA 510(k) Application Details - K091849

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K091849
Device Name	System, Test, Vitamin D
Applicant	IMMUNODIAGNOSTIC SYSTEMS, INC. 17029 EAST ENTERPRISE DR. SUITE 1 FOUNTAIN HILLS, AZ 85268 US Other 510(k) Applications for this Company
Contact	KEN GIBBS Other 510(k) Applications for this Contact
Regulation Number	862.1825   More FDA Info for this Regulation Number
Classification Product Code	MRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2009
Decision Date	06/25/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review