FDA 510(k) Application Details - K111221

Device Classification Name	Blood, Occult, Colorimetric, In Urine   More FDA Info for this Device
510(K) Number	K111221
Device Name	Blood, Occult, Colorimetric, In Urine
Applicant	ACON LABORATORIES, INC. 10125 MESA RIM RD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	QIYI XIE Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	JIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2011
Decision Date	01/18/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review