Product code LKV ยท Class 3
Enzyme Immunoassay, Fetal Fibronectin
0510(k)s in 12 months (0 all time)
0recalls in 12 months (8 all time)
1recalls that name a 510(k)
Top companies in LKV
| Company | 510(k)s | Recalls |
|---|---|---|
| Cytyc Prenatal Products/Hologic Inc. | 0 | 6 |
| Hologic, Inc. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Hologic, Inc. Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q Terminated |
LKV | None listed |
| Nov 29, 2017 | Hologic, Inc. Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200 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: 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 |
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