Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5350](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5350) → DAN — Fibrinopeptide A, Antigen, Antiserum, Control

# DAN · Fibrinopeptide A, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5350 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN

## Overview

- **Product Code:** DAN
- **Device Name:** Fibrinopeptide A, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5350](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5350)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **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](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN/K884496.md) | RIA/MAT FPA TEST KIT | Altana, Inc. | Nov 16, 1988 | SESE |
| [K854384](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN/K854384.md) | ASSERACHROM FPA KIT | American Bioproducts Co. | Feb 4, 1986 | SESE |
| [K821151](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN/K821151.md) | RIA-QUANT FPA TEST KIT | Mallinckrodt Critical Care | Jul 22, 1982 | SESE |

## Top Applicants

- Mallinckrodt Critical Care — 1 clearance
- American Bioproducts Co. — 1 clearance
- Altana, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN)

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