DAN · Fibrinopeptide A, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5350 · Class 2
Overview
| Product Code | DAN |
|---|---|
| Device Name | Fibrinopeptide A, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5350 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A fibrinopeptide A immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may aid in the diagnosis and treatment of certain blood-clotting disorders.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884496 | RIA/MAT FPA TEST KIT | Altana, Inc. | Nov 16, 1988 | SESE |
| K854384 | ASSERACHROM FPA KIT | American Bioproducts Co. | Feb 4, 1986 | SESE |
| K821151 | RIA-QUANT FPA TEST KIT | Mallinckrodt Critical Care | Jul 22, 1982 | SESE |
Top Applicants
- Altana, Inc. — 1 clearance
- American Bioproducts Co. — 1 clearance
- Mallinckrodt Critical Care — 1 clearance
