510(k) K123986 ยท OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1
ACTIM PROM
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Jan 9, 2014 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123986
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2024 | ACTIM OY Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane Open, Classified |
OAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.