Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5260](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5260) → LNJ — Analyzer, Chromosome, Automated

# LNJ · Analyzer, Chromosome, Automated

_Hematology · 21 CFR 864.5260 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ

## Overview

- **Product Code:** LNJ
- **Device Name:** Analyzer, Chromosome, Automated
- **Regulation:** [21 CFR 864.5260](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5260)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K050236](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K050236.md) | FISHVIEW | Applied Spectral Imaging , Ltd. | Jun 27, 2005 | SESE |
| [K012103](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K012103.md) | BANDVIEW SYSTEM | Applied Spectral Imaging , Ltd. | Sep 14, 2001 | SESE |
| [K940240](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K940240.md) | IKAROS | Metasystems GmbH | Feb 24, 1995 | SESE |
| [K912085](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K912085.md) | ACLAIMS-IS | W-Technology | Oct 31, 1991 | SESE |
| [K902311](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K902311.md) | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | Applied Imaging Corp. | Aug 20, 1990 | SESE |
| [K895095](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K895095.md) | AKS II | Amoco Technology Co. | Feb 9, 1990 | SESE |
| [K872755](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K872755.md) | KARYOTEC 100 | Amcor Electronics, Ltd. | Sep 1, 1987 | SESE |
| [K864955](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K864955.md) | CYTOSCAN | Image Recognition Systems , Ltd. | Mar 16, 1987 | SESE |
| [K861974](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K861974.md) | PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST | Perceptive Systems, Inc. | Aug 4, 1986 | SESE |
| [K851508](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K851508.md) | NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS | Nikon, Inc. | Jul 12, 1985 | SESE |
| [K851174](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ/K851174.md) | METACHROME | Potomac Medical System | May 23, 1985 | SESE |

## Top Applicants

- Applied Spectral Imaging , Ltd. — 2 clearances
- Amcor Electronics, Ltd. — 1 clearance
- Amoco Technology Co. — 1 clearance
- Applied Imaging Corp. — 1 clearance
- Image Recognition Systems , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LNJ)

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