FDA 510(k) Application Details - K192957

Device Classification Name	Nitroprusside, Ketones (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K192957
Device Name	Nitroprusside, Ketones (Urinary, Non-Quant.)
Applicant	Vivachek Biotech (Hangzhou) Co., Ltd 1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Hangzhou 311100 CN Other 510(k) Applications for this Company
Contact	Mark Qian 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	10/21/2019
Decision Date	06/05/2020
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