FDA 510(k) Application Details - K990873

Device Classification Name	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)   More FDA Info for this Device
510(K) Number	K990873
Device Name	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Applicant	AMERITEK, INC. 7030 35TH AVE., N.E. SEATTLE, WA 98115 US Other 510(k) Applications for this Company
Contact	K.C. YEE 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	03/16/1999
Decision Date	09/01/1999
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