510(k) BK970003
- Device
- Blood Grouping View Boxes
- Applicant
- Gamma Biologicals, Inc.
- 510(k) number
- BK970003
- Product code
- KSY
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1997-05-30
- Date received
- 1997-02-10
- Regulation
- 864.9185
- Classification name
- Boxes, View, Blood Grouping
- 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
Other 510(k) Records For Product Code KSY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K792306 | RH VIEWBOX | Tekpro | 1979-12-04 |
Legacy Summary#
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FDA Review#
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