510(k) BK120046
- 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
- Diagnostic Grifols, S. A.
- 510(k) number
- BK120046
- Product code
- PBC
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2013-07-19
- Date received
- 2012-09-05
- Regulation
- 864.9175
- Classification name
- Manual Blood Grouping And Antibody Test Systems
- 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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