Hemoglobin F Quantitation
The Hemoglobin F Quantitation test is a hematology diagnostic device used to measure the quantity of fetal hemoglobin (HbF) in blood samples, which is clinically important in the diagnosis and monitoring of sickle cell disease, beta-thalassemia, hereditary persistence of fetal hemoglobin, and other hemoglobinopathies. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. It carries product code JPC and is regulated under 21 CFR 864.7455, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JPC
- Device Class
- FDA class 2
- Regulation Number
- 864.7455
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K820630 | QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL | Jun 25, 1982 | Substantially Equivalent | Isolab, Inc. |