# LOK · Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

_ ·  · Class 3_

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

## Overview

- **Product Code:** LOK
- **Device Name:** Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P120008](/device/P120008.md) | ABBOTT ARCHITECT AFP ASSAY | Abbott Laboratories | Nov 28, 2012 | APPR |
| [P010007](/device/P010007.md) | IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP | Siemens Healthcare Diagnostics, Inc. | Nov 9, 2001 | APPR |
| [P980041](/device/P980041.md) | ACCESS AFP IMMUNOASSAY SYSTEM | Beckman Coulter, Inc. | Feb 8, 1999 | APPR |
| [P970037](/device/P970037.md) | AUTODELFIA HAFP TEST KIT | Revvity, Inc. | Mar 31, 1998 | APPR |
| [P930036](/device/P930036.md) | ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | Sep 29, 1995 | APPR |
| [P790032](/device/P790032.md) | GAMMA DAB (125I) AFP RIA KIT | Incstar Corp. | Apr 30, 1986 | APWD |
| [P780005](/device/P780005.md) | ABBOTT AFP | Abbott Laboratories | Jun 25, 1984 | APWD |
| [P780006](/device/P780006.md) | AMERSHAM AFP | Ortho Clinical Diagnostics | Jun 7, 1984 | APWD |
| [P800025](/device/P800025.md) | QUANTITOPE 125I AFP KIT AND CONTROL SERUM | Bio-Rad Laboratories, Inc. | Jan 13, 1984 | APWD |
| [P760001](/device/P760001.md) | AFP RIA KIT | Alere, Inc. | Jan 13, 1984 | APWD |
| [P820060](/device/P820060.md) | ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER | Abbott Laboratories | Jun 21, 1983 | APWD |

## Top Applicants

- Abbott Laboratories — 3 clearances
- Siemens Healthcare Diagnostics, Inc. — 2 clearances
- Alere, Inc. — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
- Bio-Rad Laboratories, Inc. — 1 clearance

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

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