510(k) BK970038
- Device
- Automated Differential Cell Counter
- Applicant
- Becton Dickinson Immunocytometry Systems
- 510(k) number
- BK970038
- Product code
- GKZ
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1999-02-04
- Date received
- 1997-09-22
- Regulation
- 864.5220
- Classification name
- Counter, Differential Cell
- 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
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Legacy Summary#
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FDA Review#
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