Fibrin Monomer Paracoagulation
A fibrin monomer paracoagulation test is a laboratory assay used to detect soluble fibrin monomers and fibrin degradation products in plasma, providing evidence of intravascular coagulation and fibrinolysis, such as in disseminated intravascular coagulation (DIC). It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JBN, regulated under 21 CFR 864.7300, within the Hematology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JBN
- Device Class
- FDA class 2
- Regulation Number
- 864.7300
- 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 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.