510(k) BK120021
- Device
- Test, Syphilis, Treponema (FOR DONOR TESTING)
- Applicant
- Immucor, Inc.
- 510(k) number
- BK120021
- Product code
- MYR
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2012-10-24
- Date received
- 2012-05-01
- 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) Traditio
- Third party reviewed
- No
Legacy Summary#
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FDA Review#
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