510(k) BK960077
- Device
- Blood Bank Centrifuges For In Vitro Diagnostic Use
- Applicant
- Gamma Biologicals, Inc.
- 510(k) number
- BK960077
- Product code
- KSO
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1997-09-18
- Date received
- 1996-10-15
- Regulation
- 864.9275
- Classification name
- Centrifuge, Blood-bank For In Vitro Diagnostic Use
- 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 KSO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K780281 | IMMUFUGE DISP. LINER | Dade, Baxter Travenol Diagnostics, Inc. | 1978-03-02 |
Legacy Summary#
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
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