Celltrifuge II
FDA 510(k) K801233 · Travenol Laboratories, S.A.
510(k) numberK801233
Submission
- Device name
- Celltrifuge II
- Applicant
- Travenol Laboratories, S.A.
Mchenry, IL, US - Received
- May 27, 1980
- Decision date
- October 31, 1980
- 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
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| 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 |
| 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 |
| K771258 | Blood Cell Separator 2997GKT · Traditional | Intl. Business Machines | 09/06/1977SE |
| K760856 | Blood Cell Processor Model 2 IBM 2991GKT · Traditional | Intl. Business Machines | 01/10/1977SE |
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Questions and answers
When was Celltrifuge II cleared by the FDA?
Celltrifuge II (K801233) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 157 days after the submission was received.
What is the product code of K801233?
The FDA product code is GKT – Separator, Automated, Blood Cell, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 864.9245.