SD Biosensor, Inc.
FDA Regulatory Profile
SD Biosensor, Inc. appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1594-2023, Class I) was initiated on March 31, 2023. Its most recent 510(k) clearance was granted on October 17, 2017.
Summary
- Total Recalls
- 2 (2 Class I)
- 510(k) Clearances
- 6
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1594-2023 | Class I | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code | March 31, 2023 |
| Z-0719-2022 | Class I | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immu | January 31, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, | October 17, 2017 |
| K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose | June 24, 2016 |
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System | November 24, 2015 |
| K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | September 30, 2015 |
| K132929 | SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD G | August 5, 2015 |
| K123517 | GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM | January 17, 2014 |