Ayerst Laboratories: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Ayerst Laboratories”, plus 1 PMA decision, across 1 product code. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N17622 | PMA | FLOURESCEIN SODIUM OPHTHALMIC STRIPS | 1976-05-28 |
Recalls
openFDA lists no recalls under a recalling firm named Ayerst Laboratories.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ayerst Laboratories?
FDA lists 0 510(k) clearances under the applicant name “Ayerst Laboratories”, plus 1 PMA decision, across 1 product code. Filings under other applicant names, such as subsidiaries, are not included.
Next steps
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.