← Product Code [DAN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN) · K884496

# RIA/MAT FPA TEST KIT (K884496)

_Altana, Inc. · DAN · Nov 16, 1988 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN/K884496

## Device Facts

- **Applicant:** Altana, Inc.
- **Product Code:** [DAN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN.md)
- **Decision Date:** Nov 16, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5350
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN/K884496](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN/K884496)

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