Company ยท KR
Sd Biosensor
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2017. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2017 | K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Hom Sd Biosensor, KR | NBW |
| Jun 24, 2016 | K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System Sd Biosensor, KR | NBW |
| Nov 24, 2015 | K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System Sd Biosensor, KR | NBW |
| Sep 30, 2015 | K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set Sd Biosensor, Inc., KR | LCP |
| Aug 5, 2015 | K132929 | SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SY Sd Biosensor, Inc. | NBW |
| Jan 17, 2014 | K123517 | GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM Sd Biosensor | NBW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2023 | SD Biosensor, Inc. Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728) Open, Classified |
QKP | None listed |
| Jan 31, 2022 | SD Biosensor, Inc. STANDARD Q COVID-19 Ag Home Test
STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample Open, Classified |
QKP | None listed |