Hematocrit, Tube, Rack, Sealer, Holder
Hematocrit Tube, Rack, Sealer, and Holder (product code GHY) are the accessory components and consumables used in the microhematocrit method for determining packed red cell volume, including the capillary tubes, sealing clay, centrifuge tube holders, and reading guides. 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
- GHY
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.