Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7735](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7735) → JPF — Prothrombin-Proconvertin And Thrombotest

# JPF · Prothrombin-Proconvertin And Thrombotest

_Hematology · 21 CFR 864.7735 · Class 2_

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

## Overview

- **Product Code:** JPF
- **Device Name:** Prothrombin-Proconvertin And Thrombotest
- **Regulation:** [21 CFR 864.7735](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7735)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

The prothrombin-proconvertin test and thrombotest are devices used in the regulation of coumarin therapy (administration of a coumarin anticoagulant such as sodium warfarin in the treatment of venous thrombosis and pulmonary embolism) and as a diagnostic test in conjunction with, or in place of, the Quick prothrombin time test to detect coagulation disorders.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPF](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPF)

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