Fibrinopeptide A, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting fibrinopeptide A, a small peptide cleaved from fibrinogen by thrombin during coagulation, serving as a marker of active clot formation. The kit includes antigen, antiserum, and control components for in vitro immunoassay testing in clinical laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAN, regulated under 21 CFR 866.5350, within the Immunology specialty.
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Basic Information
- Product Code
- DAN
- Device Class
- FDA class 2
- Regulation Number
- 866.5350
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K884496 | RIA/MAT FPA TEST KIT | Nov 16, 1988 | Substantially Equivalent | Altana, Inc. |
| K854384 | ASSERACHROM FPA KIT | Feb 04, 1986 | Substantially Equivalent | American Bioproducts Co. |
| K821151 | RIA-QUANT FPA TEST KIT | Jul 22, 1982 | Substantially Equivalent | Mallinckrodt Critical Care |