← Product Code [KFF](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF) · K943514

# THE HEPANORM HBPM/LMWH KIT (K943514)

_American Bioproducts Co. · KFF · Sep 26, 1995 · Hematology · SESK_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K943514

## Device Facts

- **Applicant:** American Bioproducts Co.
- **Product Code:** [KFF](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF.md)
- **Decision Date:** Sep 26, 1995
- **Decision:** SESK
- **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/K943514](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K943514)

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