← Product Code [KFF](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF) · K781479

# HEPARIN ASSAY (K781479)

_Dade, Baxter Travenol Diagnostics, Inc. · KFF · Feb 15, 1979 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K781479

## Device Facts

- **Applicant:** Dade, Baxter Travenol Diagnostics, Inc.
- **Product Code:** [KFF](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF.md)
- **Decision Date:** Feb 15, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7525
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K781479](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K781479)

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