FDA 510(k) Application Details - K170587

Device Classification Name	Nitroprusside, Ketones (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K170587
Device Name	Nitroprusside, Ketones (Urinary, Non-Quant.)
Applicant	ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Qiyi Xie 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	02/28/2017
Decision Date	07/06/2017
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