510(k) K900225 ยท LIO Device, Specimen Collection
ROMCHECK SPECIMEN COLLECTION KIT
| Applicant | Adeza Biomedical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 2, 1990 |
| Received | Jan 17, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2025 | Hologic, Inc. The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party sup Open, Classified |
LIO | None listed |
| Mar 16, 2011 | Cytyc Prenatal Products/Hologic Inc. Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 0797 Specimen Collection Kit (8 pack); manufactured by Hologic, Sunnyvale, CA.
Medical device for use in Terminated |
LKV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.