Device, Automated Sedimentation Rate
Device, Automated Sedimentation Rate (product code GKB) is an automated instrument used to measure the erythrocyte sedimentation rate (ESR), a nonspecific indicator of systemic inflammation and tissue damage, providing faster and more standardized results than the traditional manual Westergren method. This device is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.5800 in the Hematology specialty (HE), this device carries no special regulatory flags.
Basic Information
- Product Code
- GKB
- Device Class
- FDA class 1
- Regulation Number
- 864.5800
- 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 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.