← Product Code [GFO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO) · K923731

# STACLOT LA TEST KIT (K923731)

_American Bioproducts Co. · GFO · Dec 23, 1992 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K923731

## Device Facts

- **Applicant:** American Bioproducts Co.
- **Product Code:** [GFO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO.md)
- **Decision Date:** Dec 23, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7925
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K923731](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K923731)

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