FDA 510(k) Application Details - K242767

Device Classification Name	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)   More FDA Info for this Device
510(K) Number	K242767
Device Name	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Applicant	Safecare Biotech (Hangzhou) Co., Ltd. 18 Haishu Road, Yuhang District Hangzhou 311121 CN Other 510(k) Applications for this Company
Contact	Selina Zhang Other 510(k) Applications for this Contact
Regulation Number	862.1510   More FDA Info for this Regulation Number
Classification Product Code	JMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2024
Decision Date	01/10/2025
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