← Product Code [GFO](/productcode/GFO) · K884485

# KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (K884485)

_King Diagnostics, Inc. · GFO · Dec 28, 1988 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K884485

## Device Facts

- **Applicant:** King Diagnostics, Inc.
- **Product Code:** [GFO](/productcode/GFO.md)
- **Decision Date:** Dec 28, 1988
- **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-staging.innolitics.com/device/K884485](https://fda-staging.innolitics.com/device/K884485)

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