Separator, Automated, Blood Cell, Diagnostic
Separator, Automated, Blood Cell, Diagnostic (product code GKT) is an automated laboratory device used to separate different blood cell populations from whole blood for subsequent diagnostic analysis, such as isolating white cells, red cells, or platelets for specialized hematological testing. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.9245 in the Hematology specialty (HE), this device carries no flags for implantation, life support, GMP exemption, or third-party review.
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Basic Information
- Product Code
- GKT
- Device Class
- FDA class 2
- Regulation Number
- 864.9245
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K200530 | AMICUS Separator System | Sep 11, 2020 | Substantially Equivalent | Fresenius Kabi AG |
| K162462 | AMICUS Separator System, AMICUS Separator System; Refurbished | Nov 23, 2016 | Substantially Equivalent | Fresenius Kabi USA,Llc |
| K822521 | AUTOMATED BLOOD CELL SEPARATOR | Sep 30, 1982 | Substantially Equivalent | Cryosan, Inc. |
| K820396 | AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR | Apr 27, 1982 | Substantially Equivalent | Pheragen Technology Corp. |
| K801233 | CELLTRIFUGE II | Oct 31, 1980 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K791106 | STERILE, DISPOSABLE CENTRIFUGE BOWL | Aug 10, 1979 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K790105 | TERUMO IMUGARD | May 24, 1979 | Substantially Equivalent | Terumo America, Inc. |
| K781803 | FILTER, EYRPUR DISPOSABLE LEUKOCITE | Jan 17, 1979 | Substantially Equivalent | Metrix Teknika, Inc. |
| K771258 | BLOOD CELL SEPARATOR 2997 | Sep 06, 1977 | Substantially Equivalent | Intl. Business Machines |
| K760856 | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | Jan 10, 1977 | Substantially Equivalent | Intl. Business Machines |
FEI Numbers
This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.