← Product Code [GFO](/productcode/GFO) · K921396

# PLATELIN L (K921396)

_Organon Teknika Corp. · GFO · Oct 19, 1992 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K921396

## Device Facts

- **Applicant:** Organon Teknika Corp.
- **Product Code:** [GFO](/productcode/GFO.md)
- **Decision Date:** Oct 19, 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/device/K921396](https://fda.innolitics.com/device/K921396)

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