← Product Code [GFO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO) · K891337

# THROMBOSCREEN APTT REAGENT (K891337)

_Pacific Hemostasis · GFO · Apr 21, 1989 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K891337

## Device Facts

- **Applicant:** Pacific Hemostasis
- **Product Code:** [GFO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO.md)
- **Decision Date:** Apr 21, 1989
- **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/K891337](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K891337)

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