Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Empowered Diagnostics LLC with 2 device recalls and 1 warning letter. The most recent is a warning letter dated Oct 6, 2022: Warning letter: CAPA, Complaint handling, Design controls.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 6, 2022 | Warning letter: CAPA, Complaint handling, Design controlsCDRH | Warning letters |
| Dec 22, 2021 | CovClear COVID-19 Rapid Antigen Test, ATG 900-031Class I · COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clea | Device recalls |
| Dec 22, 2021 | ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60Class I · COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clea | 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
