510(k) BK170045
- Device
- Automated Blood Cell Separators
- Applicant
- Haemonetics Corporation
- 510(k) number
- BK170045
- Product code
- GKT
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2017-07-25
- Date received
- 2017-04-24
- Regulation
- 864.9245
- Classification name
- Separator, Automated, Blood Cell, Diagnostic
- 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 GKT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200530 | AMICUS Separator System | Fresenius Kabi AG | 2020-09-11 |
| K162462 | AMICUS Separator System, AMICUS Separator System; Refurbished | Fresenius Kabi USA,Llc | 2016-11-23 |
| K822521 | AUTOMATED BLOOD CELL SEPARATOR | Cryosan, Inc. | 1982-09-30 |
| K820396 | AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR | Pheragen Technology Corp. | 1982-04-27 |
| K801233 | CELLTRIFUGE II | Travenol Laboratories, S.A. | 1980-10-31 |
| K791106 | STERILE, DISPOSABLE CENTRIFUGE BOWL | Travenol Laboratories, S.A. | 1979-08-10 |
| K790105 | TERUMO IMUGARD | Terumo America, Inc. | 1979-05-24 |
| K781803 | FILTER, EYRPUR DISPOSABLE LEUKOCITE | Metrix Teknika, Inc. | 1979-01-17 |
| K771258 | BLOOD CELL SEPARATOR 2997 | Intl. Business Machines | 1977-09-06 |
| K760856 | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | Intl. Business Machines | 1977-01-10 |
Legacy Summary#
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FDA Review#
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