510(k) BK070063
- Device
- Bacterial Detection Systems For Platelet Transfusion Products
- Applicant
- Haemonetics Manufacturing Inc.
- 510(k) number
- BK070063
- Product code
- MZC
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2008-01-26
- Date received
- 2007-10-12
- Regulation
- 866.2560
- Classification name
- System, Detection, Bacterial, For Platelet Transfusion Products
- 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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