510(k) BK080051
- Device
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Applicant
- ALBA Bioscience Limited (doing Business As Quotient)
- 510(k) number
- BK080051
- Product code
- MTI
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2009-04-08
- Date received
- 2008-09-29
- Regulation
- 510(k) Premarket Notification
- Classification name
- Kit, Cell Screening, Fetal
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Legacy Summary#
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FDA Review#
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