Product Code: JBB
FDA class 2
21 CFR 864.7825
Solubility, Hemoglobin, Abnormal
Hematology
Abnormal hemoglobin solubility reagents and test systems are used in clinical hematology laboratories to screen blood samples for the presence of hemoglobin S and other sickling hemoglobins by exploiting their reduced solubility under deoxygenated conditions, aiding in the diagnosis of sickle cell disease and related disorders. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JBB, regulated under 21 CFR 864.7825, within the Hematology medical specialty. This device is eligible for third-party review.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
4
Basic Information
- Product Code
- JBB
- Device Class
- FDA class 2
- Regulation Number
- 864.7825
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.