Home › Device types › LKV
Enzyme Immunoassay, Fetal Fibronectin
FDA product code LKV · Class 3 · Unknown
6
Registered devices
4
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-29 | Hologic, Inc. | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved th |
| 2017-11-29 | Hologic, Inc. | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved th |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full te |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full te |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full te |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full te |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full te |
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