510(k) BK030007
- Device
- Test, Syphilis, Treponema (FOR DONOR TESTING)
- Applicant
- Fujirebio Diagnostics, Inc.
- 510(k) number
- BK030007
- Product code
- MYR
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2003-02-21
- Date received
- 2003-02-07
- Regulation
- 866.3830
- Classification name
- Test, Donor, Syphilis, Antigens, Treponemal
- 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) Special
- Third party reviewed
- No
Legacy Summary#
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FDA Review#
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