Product code JPC— Hematology
QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL
- Classification name
- Hemoglobin F Quantitation
- Device class
- Class 2
- Regulation
- 21 CFR 864.7455
- Advisory panel
- Hematology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code JPC
FDA has cleared device under product code JPC, all in 1982, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code JPC
Recent clearances under product code JPC
Data sourced from openFDA. This site is unofficial and independent of the FDA.