Centrifuge, Hematocrit
Centrifuge, Hematocrit (product code GKG) is a specialized laboratory centrifuge designed to spin microhematocrit capillary tubes at high speed to pack red blood cells, enabling the rapid determination of hematocrit as part of a complete blood count or anemia workup. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.6400 in the Hematology specialty (HE), this device carries no special regulatory flags.
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Basic Information
- Product Code
- GKG
- Device Class
- FDA class 2
- Regulation Number
- 864.6400
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K961803 | SPUNCRIT (MODEL DRC-40) | Jul 05, 1996 | Substantially Equivalent | Micro Diagnostics Corp. |
| K955795 | MULTI-CENTRIFUGE | Mar 29, 1996 | Substantially Equivalent | Novonx, Inc. |
| K930415 | MICROHEMATOCRIT ROTOR | Mar 23, 1993 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K925863 | SPUNCRIT | Feb 05, 1993 | Substantially Equivalent | bioMerieux, Inc. |
| K920207 | HERMLE Z230H | Jun 09, 1992 | Substantially Equivalent | Labnet Intl., Inc. |
| K920759 | CRITSPIN MICRO-HEMATOCRIT | Apr 29, 1992 | Substantially Equivalent | Stat-Spin Technologies |
| K913128 | HEMATASTAT C-70B | Sep 23, 1991 | Substantially Equivalent | Separation Technology, Inc. |
| K890849 | HEMATASTAT H-70 | Mar 21, 1989 | Substantially Equivalent | Separation Technology, Inc. |
| K822445 | HCT CENTRIFUGE | Sep 14, 1982 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K821803 | QBC CENTRIFUGAL HEMATOLOGY SYSTEM | Sep 14, 1982 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K813033 | CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY | Apr 09, 1982 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.