# MVC · System, Test, Her-2/Neu, Ihc

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/MVC

## Overview

- **Product Code:** MVC
- **Device Name:** System, Test, Her-2/Neu, Ihc
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P090015](/device/P090015.md) | BOND ORACLE HER2 IHC SYSTEM | Leica Biosystems | Apr 18, 2012 | APPR |
| [P040030](/device/P040030.md) | INSITE HER-2/NEU KIT | Biogenex Laboratories, Inc. | Dec 22, 2004 | APWD |
| [P990081](/device/P990081.md) | PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Nov 28, 2000 | APPR |
| [P980018](/device/P980018.md) | DAKO HERCEPTEST | Agilent Technologies Singapore (International) Pte , Ltd. | Sep 25, 1998 | APPR |

## Top Applicants

- Agilent Technologies Singapore (International) Pte , Ltd. — 1 clearance
- Biogenex Laboratories, Inc. — 1 clearance
- Leica Biosystems — 1 clearance
- Ventana Medical Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/MVC](https://fda.innolitics.com/productcode/MVC)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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