Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7300](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7300) → JBN — Fibrin Monomer Paracoagulation

# JBN · Fibrin Monomer Paracoagulation

_Hematology · 21 CFR 864.7300 · Class 2_

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

## Overview

- **Product Code:** JBN
- **Device Name:** Fibrin Monomer Paracoagulation
- **Regulation:** [21 CFR 864.7300](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7300)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## 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. The special control for this device is FDA's “In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.” See § 864.1(d) for information on obtaining this document.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K854015](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBN/K854015.md) | FS TEST KIT | American Bioproducts Co. | Mar 6, 1986 | SESE |
| [K781814](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBN/K781814.md) | SULFATE, FIBRIQUIK PROTAMINE | General Diagnostics | Nov 8, 1978 | SESE |

## Top Applicants

- American Bioproducts Co. — 1 clearance
- General Diagnostics — 1 clearance

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

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