← Product Code [DAN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN) · K821151

# RIA-QUANT FPA TEST KIT (K821151)

_Mallinckrodt Critical Care · DAN · Jul 22, 1982 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN/K821151

## Device Facts

- **Applicant:** Mallinckrodt Critical Care
- **Product Code:** [DAN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN.md)
- **Decision Date:** Jul 22, 1982
- **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/K821151](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAN/K821151)

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