Product code GKT
- Device name
- Separator, Automated, Blood Cell, Diagnostic
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9245
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
Related GUDID Devices#
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|---|---|---|---|
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| 10812747019347 | Haemonetics® PCS®2 & NexSys PCS® Systems | HAEMONETICS CORPORATION | 2024-07-19 |
| 10812747019279 | Haemonetics® PCS®2 & NexSys PCS® Systems | HAEMONETICS CORPORATION | 2024-07-19 |
| 10812747019736 | Haemonetics® NexSys PCS® System | HAEMONETICS CORPORATION | 2024-07-17 |
| 00810020441635 | Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual | Fresenius Kabi AG | 2024-01-24 |
| 10812747019330 | Haemonetics® NexSys PCS® System | HAEMONETICS CORPORATION | 2023-06-29 |
| 00810020440768 | AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike | Fresenius Kabi AG | 2023-05-22 |
| 00810020440270 | AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike | Fresenius Kabi AG | 2023-05-22 |
| 00810020441116 | PLASMACELL Xi Disposable Set with SPIKESMART | Fresenius Kabi AG | 2023-02-24 |
| 10812747011716 | Haemonetics® PCS®2, NexSys PCS® & MCS®+ Systems | HAEMONETICS CORPORATION | 2022-10-26 |
| 00810020440713 | Amicus Double Needle Advanced Kit with Platelet Additive Solution Connector | Fresenius Kabi AG | 2022-04-11 |
| 00810020440706 | Amicus Single Needle Advanced Kit with Platelet Additive Solution Connector | Fresenius Kabi AG | 2022-04-11 |
| 00810020440171 | AMICUS Separator Life Extension Software | Fresenius Kabi AG | 2020-11-18 |
| 00810020440164 | AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly | Fresenius Kabi AG | 2020-10-20 |
| 10812747011686 | Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems | HAEMONETICS CORPORATION | 2018-02-16 |
| 10812747011761 | Haemonetics® PCS®2 & NexSys PCS™ Systems | HAEMONETICS CORPORATION | 2018-02-16 |
| 10812747011754 | Haemonetics® PCS®2 & NexSys PCS™ Systems | HAEMONETICS CORPORATION | 2018-02-16 |
| 10812747011730 | Haemonetics® PCS®2 & NexSys PCS™ Systems | HAEMONETICS CORPORATION | 2018-02-16 |
| 10812747011709 | Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems | HAEMONETICS CORPORATION | 2018-02-16 |
| 10812747011693 | Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems | HAEMONETICS CORPORATION | 2018-02-16 |
| 10812747013505 | HAEMONETICS MCS+ (LN8150) AND RBC APHERISIS | HAEMONETICS CORPORATION | 2017-04-17 |
| 10812747013482 | HAEMONETICS MCS+ (LN8150) for RBC APHERESIS | HAEMONETICS CORPORATION | 2017-04-17 |
| 10812747012492 | MCS+ | HAEMONETICS CORPORATION | 2017-04-17 |
| 10812747012485 | MCS+ | HAEMONETICS CORPORATION | 2017-04-17 |
| 10812747013499 | HAEMONETICS MCS+ (LN8150) RBC APHERESIS | HAEMONETICS CORPORATION | 2017-03-20 |
| 10812747013475 | HAEMONETICS MCS+ (LN8150) RBC APHERESIS | HAEMONETICS CORPORATION | 2017-03-20 |
| M5264C23041 | Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter | Fresenius Kabi AG | 2017-02-18 |
| 10812747013512 | MCS+ (LN8150) RBC APHERESIS | HAEMONETICS CORPORATION | 2017-02-08 |
| 10812747012270 | HAEMONETICS MCS+ (LN9000) SYSTEM | HAEMONETICS CORPORATION | 2017-02-08 |
| 10812747012096 | HAEMONETICS MCS+ APHERESIS SYSTEM | HAEMONETICS CORPORATION | 2017-01-31 |