FDA 510(k) Application Details - K072640

Device Classification Name	Urinalysis Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K072640
Device Name	Urinalysis Controls (Assayed And Unassayed)
Applicant	IRIS DIAGNOSTICS 9172 ETON AVE. CHATSWORTH, CA 91311 US Other 510(k) Applications for this Company
Contact	GERALD HADDOCK Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2007
Decision Date	12/21/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review