LNJ · Analyzer, Chromosome, Automated
Hematology · 21 CFR 864.5260 · Class 2
Overview
| Product Code | LNJ |
|---|---|
| Device Name | Analyzer, Chromosome, Automated |
| Regulation | 21 CFR 864.5260 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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 | FISHVIEW | Applied Spectral Imaging , Ltd. | Jun 27, 2005 | SESE |
| K012103 | BANDVIEW SYSTEM | Applied Spectral Imaging , Ltd. | Sep 14, 2001 | SESE |
| K940240 | IKAROS | Metasystems GmbH | Feb 24, 1995 | SESE |
| K912085 | ACLAIMS-IS | W-Technology | Oct 31, 1991 | SESE |
| K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | Applied Imaging Corp. | Aug 20, 1990 | SESE |
| K895095 | AKS II | Amoco Technology Co. | Feb 9, 1990 | SESE |
| K872755 | KARYOTEC 100 | Amcor Electronics, Ltd. | Sep 1, 1987 | SESE |
| K864955 | CYTOSCAN | Image Recognition Systems , Ltd. | Mar 16, 1987 | SESE |
| K861974 | PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST | Perceptive Systems, Inc. | Aug 4, 1986 | SESE |
| K851508 | NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS | Nikon, Inc. | Jul 12, 1985 | SESE |
| K851174 | 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
