FDA 510(k) Application Details - K003987

Device Classification Name	Nitroprusside, Ketones (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K003987
Device Name	Nitroprusside, Ketones (Urinary, Non-Quant.)
Applicant	TECO DIAGNOSTICS 4925 EAST HUNTER AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	DINDO CARRILLO Other 510(k) Applications for this Contact
Regulation Number	862.1435   More FDA Info for this Regulation Number
Classification Product Code	JIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2000
Decision Date	04/26/2001
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