FDA 510(k) Application Details - K120124

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K120124
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	ACON LABORATORIES, INC. 10125 MESA RIM ROAD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	QIYI XIE Other 510(k) Applications for this Contact
Regulation Number	862.1340   More FDA Info for this Regulation Number
Classification Product Code	JIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2012
Decision Date	03/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review