FDA 510(k) Application Details - K033114

Device Classification Name	Nitroprusside, Ketones (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K033114
Device Name	Nitroprusside, Ketones (Urinary, Non-Quant.)
Applicant	NEO DIAGNOSTICS, INC 10532 WALKER ST. SUITE B CYPRESS, CA 90630 US Other 510(k) Applications for this Company
Contact	SUNG PYO 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	09/30/2003
Decision Date	04/26/2004
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