Blood Cell Separator 2997
FDA 510(k) K771258 · Intl. Business Machines
510(k) numberK771258
Submission
- Device name
- Blood Cell Separator 2997
- Applicant
- Intl. Business Machines
Mchenry, IL, US - Received
- July 12, 1977
- Decision date
- September 6, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKT – Separator, Automated, Blood Cell, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9245
- Specialty
- Hematology
Other 510(k)s with product code GKT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200530 | AMICUS Separator SystemGKT · Traditional | Fresenius Kabi AG | 09/11/2020SE |
| K162462 | AMICUS Separator System, AMICUS Separator System; RefurbishedGKT · Traditional | Fresenius Kabi USA,Llc | 11/23/2016SE |
| K822521 | Automated Blood Cell SeparatorGKT · Traditional | Cryosan, Inc. | 09/30/1982SE |
| K820396 | Automated Blood Cell Separ. Disp. SftwrGKT · Traditional | Pheragen Technology Corp. | 04/27/1982SE |
| K801233 | Celltrifuge IIGKT · Traditional | Travenol Laboratories, S.A. | 10/31/1980SE |
| K791106 | Sterile, Disposable Centrifuge BowlGKT · Traditional | Travenol Laboratories, S.A. | 08/10/1979SE |
| K790105 | Terumo ImugardGKT · Traditional | Terumo America, Inc. | 05/24/1979SE |
| K781803 | Filter, Eyrpur Disposable LeukociteGKT · Traditional | Metrix Teknika, Inc. | 01/17/1979SE |
| K760856 | Blood Cell Processor Model 2 IBM 2991GKT · Traditional | Intl. Business Machines | 01/10/1977SE |
More from Intl. Business Machines
| 510(k) | Device | Decision |
|---|---|---|
| K831004 | Automated 8400 Blood Cell SeparatorLKN · Traditional | 09/12/1983SE |
| K830163 | IBM 588 Digital ECG Acquisition/AnalysisDSI · Traditional | 02/18/1983SE |
| K812355 | IBM 2991 Blood Cell Processor Mod. 1 & 2CAC · Traditional | 09/09/1981SE |
| K810989 | IBM 5880 Acquisition & Analysis Cart TelLOS · Traditional | 05/01/1981SE |
| K810988 | IBM 5885 Digital ECG Acquisition CartDPS · Traditional | 05/01/1981SE |
| K772353 | EKG Acquisition & Analysis CartLOS · Traditional | 01/06/1978SE |
| K760856 | Blood Cell Processor Model 2 IBM 2991GKT · Traditional | 01/10/1977SE |
Questions and answers
When was Blood Cell Separator 2997 cleared by the FDA?
Blood Cell Separator 2997 (K771258) received a 510(k) decision of Substantially Equivalent on September 6, 1977, 56 days after the submission was received.
What is the product code of K771258?
The FDA product code is GKT – Separator, Automated, Blood Cell, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 864.9245.