510(k) BK200546
- Device
- Test, Qualitative, For HLA, Non-Diagnostic
- Applicant
- One Lambda, Inc.
- 510(k) number
- BK200546
- Product code
- MZI
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2021-01-07
- Date received
- 2020-12-10
- Regulation
- 510(k) Premarket Notification
- Classification name
- Test, Qualitative, For Hla, Non-diagnostic
- 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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