← Product Code [GFO](/productcode/GFO) · K781104

# PLASMA COAGULATION CONT., ABNORMAL (K781104)

_Ortho Diagnostics, Inc. · GFO · Aug 10, 1978 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K781104

## Device Facts

- **Applicant:** Ortho Diagnostics, Inc.
- **Product Code:** [GFO](/productcode/GFO.md)
- **Decision Date:** Aug 10, 1978
- **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/K781104](https://fda-staging.innolitics.com/device/K781104)

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