FDA 510(k) Application Details - K103037

Device Classification Name	Test, Nitrite, Urinary, Non-Quantitative, Over The Counter   More FDA Info for this Device
510(K) Number	K103037
Device Name	Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
Applicant	IND DIAGNOSTIC, INC. 1629 FOSTERS WAY DELTA, B.C. V3M 6S7 CA Other 510(k) Applications for this Company
Contact	KAI LOU Other 510(k) Applications for this Contact
Regulation Number	862.1510   More FDA Info for this Regulation Number
Classification Product Code	NGJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2010
Decision Date	04/17/2012
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