FDA 510(k) Application Details - K993850

Device Classification Name	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)   More FDA Info for this Device
510(K) Number	K993850
Device Name	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Applicant	INTERNATIONAL NEWTECH DEVELOPMENT, INC. 1629 FOSTERS WAY DELTA, BRITISH COLUMBIA V3M 6S7 CA Other 510(k) Applications for this Company
Contact	DENNIS S.L. HONG Other 510(k) Applications for this Contact
Regulation Number	862.1510   More FDA Info for this Regulation Number
Classification Product Code	JMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/1999
Decision Date	01/03/2000
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