FDA 510(k) Application Details - K210069

Device Classification Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K210069
Device Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant	Healthy.io Ltd. 2 Ibn Gabirol St. Tel Aviv 6407702 IL Other 510(k) Applications for this Company
Contact	Ron Zohar Other 510(k) Applications for this Contact
Regulation Number	862.1645   More FDA Info for this Regulation Number
Classification Product Code	JIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2021
Decision Date	07/06/2022
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