← Product Code [GFO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO) · K900049

# APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT (K900049)

_Medical Diagnostic Technologies, Inc. · GFO · Jan 25, 1990 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K900049

## Device Facts

- **Applicant:** Medical Diagnostic Technologies, Inc.
- **Product Code:** [GFO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO.md)
- **Decision Date:** Jan 25, 1990
- **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/K900049](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K900049)

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