FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)
FDA premarket approval P920048 · decided 1995-09-21
Approval details
- PMA number
- P920048
- Trade name
- FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 1992-10-20
- Decision date
- 1995-09-21
- Days to decision
- 1066 days
- Decision code
- APPR
- Product code
- LKV
- Advisory committee
- Clinical Toxicology
- Expedited review
- Yes
- Location
- Sunnyvale, CA
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510(k) clearances by this applicant
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|---|---|---|
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| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
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