FDA 510(k) Application Details - K103387

Device Classification Name	Urinalysis Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K103387
Device Name	Urinalysis Controls (Assayed And Unassayed)
Applicant	ACON LABORATORIES, INC. 10125 MESA RIM RD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	RICHARD LENART 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	11/18/2010
Decision Date	02/02/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review