Alere, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Alere, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOK | Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | 1 | 0 |
Review panels
- Immunology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P760001 | PMA | AFP RIA KIT | 1984-01-13 |
Recalls
openFDA lists no recalls under a recalling firm named Alere, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alere Scarborough, Inc. (16 510(k)s)
- Alere Scarborough, Inc D/B/A Binax, Inc. (4 510(k)s)
- Alere Technologies AS (3 510(k)s)
- Alere San Diego, Inc. (1 510(k)s)
- Alere, San Diego, Dba Biosite INcorporated, Dba IN (1 510(k)s)
- Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen (1 510(k)s)
- Alere San Diego, Inc (Formally Biosite Incorporate (1 510(k)s)
- Alere San Diego, Incorporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alere, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Alere, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Alere, Inc.?
The most frequent FDA product codes under this applicant name are LOK (Kit, Test, Alpha-Fetoprotein For Neural Tube Defects, 1).
Next steps
- See all 0 Alere, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LOK, Alere, Inc.'s most frequent
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.