Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list SD Biosensor and its 4 subsidiaries with 140 510(k) clearances, 34 device recalls, 1 drug application and 1 warning letter. The most recent is a warning letter dated Dec 22, 2025: Warning letter: Method validation, CAPA, MDR reporting.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, SD Biosensor and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 22, 2025 | Warning letter: Method validation, CAPA, MDR reportingCDRH | Warning letters |
| Mar 20, 2025 | RevogeneK243922 · OOI | 510(k) clearances |
| Jul 3, 2023 | Premier HpSA Flex (619096)K230901 · LYR | 510(k) clearances |
| Apr 17, 2023 | Curian® Shiga ToxinK222829 · GMZ | 510(k) clearances |
| Mar 31, 2023 | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)Class I · The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may noti | Device recalls |
| Jan 26, 2023 | RevogeneK222779 · OOI | 510(k) clearances |
| Dec 19, 2022 | BreathID Hp SystemK221896 · MSQ | 510(k) clearances |
| Nov 10, 2022 | BreathID® Smart SystemK223185 · MSQ | 510(k) clearances |
| Jul 11, 2022 | RevogeneK220480 · OOI | 510(k) clearances |
| Jun 23, 2022 | BreathID Hp Lab System, BreathID Smart SystemK220494 · MSQ | 510(k) clearances |
| Jan 31, 2022 | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection ofClass I · Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
