Company
Cytyc Prenatal Products/Hologic Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LKV | Enzyme Immunoassay, Fetal Fibronectin | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2011 | Cytyc Prenatal Products/Hologic Inc. Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1202 TLiIQ Analyzer Boxed Set (includes Analyzer/Printer and QCette). manufactured by Hologic, Sunnyvale, Terminated |
LKV | 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: 1175 TLiIQ QCette ; manufactured by Hologic, Sunnyvale, CA.
Medical device for use in assessment of pret Terminated |
LKV | 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: 01166 Rapid fFN Control Kit ; manufactured by Hologic, Sunnyvale, CA.
Medical device for use in assessme Terminated |
LKV | 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: 01200/1200Q Rapid fFN Cassette Kit; manufactured by Hologic, Sunnyvale, CA.
Medical device for use in Terminated |
LKV | 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: 71738 Specimen Collection Kit (25 pack); manufactured by Hologic, Sunnyvale, CA.
Medical device for use Terminated |
LKV | 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 | K900225 |