← Product Code [DDF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDF) · K910617

# NATIVE PROTHROMBIN ANTIGEN EIA (K910617)

_Organon Teknika Corp. · DDF · May 15, 1991 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDF/K910617

## Device Facts

- **Applicant:** Organon Teknika Corp.
- **Product Code:** [DDF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDF.md)
- **Decision Date:** May 15, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5735
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDF/K910617](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDF/K910617)

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