510(k) BK980002
- Device
- Supplies, Blood-Bank
- Applicant
- Teva Medical LTD
- 510(k) number
- BK980002
- Product code
- KSS
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1998-03-02
- Date received
- 1998-01-23
- Regulation
- 864.9050
- Classification name
- Supplies, Blood-bank
- 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
- Source
- Migrated FDA.report data
Related Records
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases