Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
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 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Acon Laboratories with 93 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jul 10, 2026: Flowflex Plus RSV + Flu A/B + COVID Rapid Test.
510(k) clearances: 93
Device recalls: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
22017Records2
320182018Records3vs 2017+1
22019Records2vs 2018−1
120202020Records1vs 2019−1
02021Records0vs 2020−1
020222022Records0vs 2021+0
12023Records1vs 2022+1
220242024Records2vs 2023+1
42025Records4vs 2024+2
120262026 to dateRecords1
Latest Records
Newest first across sources; each opens the record
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
