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SD Biosensor, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1594-2023Class IPilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC CodeMarch 31, 2023
Z-0719-2022Class ISTANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immuJanuary 31, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, October 17, 2017
K153201SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood GlucoseJune 24, 2016
K151265SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring SystemNovember 24, 2015
K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetSeptember 30, 2015
K132929SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GAugust 5, 2015
K123517GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEMJanuary 17, 2014