FDA 510(k) Application Details - K060768

Device Classification Name	Nitroprusside, Ketones (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K060768
Device Name	Nitroprusside, Ketones (Urinary, Non-Quant.)
Applicant	ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. ALAMEDA, CA 94502 US Other 510(k) Applications for this Company
Contact	MARIA E TREJO 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	03/22/2006
Decision Date	04/21/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review