FDA product code LNJ: Analyzer, Chromosome, Automated
LNJ is the FDA product code for analyzer, chromosome, automated. It is a Class II device, regulated under 21 CFR 864.5260 and reviewed by the Pathology panel. FDA has cleared 11 510(k) submissions under LNJ, from 10 different applicants. The average 510(k) review took 129 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Chromosome, Automated |
| Device class | Class II |
| Regulation | 21 CFR 864.5260 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LNJ clearance
Top LNJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Spectral Imaging , Ltd. | 2 | 2005-06-27 |
| Metasystems GmbH | 1 | 1995-02-24 |
| W-Technology | 1 | 1991-10-31 |
| Applied Imaging Corp. | 1 | 1990-08-20 |
| Amoco Technology Co. | 1 | 1990-02-09 |
5 more applicants have LNJ clearances. See the full list in Caduvo.
Most recent LNJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050236 | Applied Spectral Imaging , Ltd. | FISHVIEW | 2005-06-27 | 147 |
| K012103 | Applied Spectral Imaging , Ltd. | BANDVIEW SYSTEM | 2001-09-14 | 71 |
| K940240 | Metasystems GmbH | IKAROS | 1995-02-24 | 401 |
| K912085 | W-Technology | ACLAIMS-IS | 1991-10-31 | 171 |
| K902311 | Applied Imaging Corp. | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | 1990-08-20 | 89 |
Recalls for LNJ devices
openFDA lists no recalls for product code LNJ.
Frequently asked questions
What is FDA product code LNJ?
LNJ is the FDA product code for analyzer, chromosome, automated. It is a Class II device, regulated under 21 CFR 864.5260 and reviewed by the Pathology panel.
What device class is LNJ?
Class II, regulation 21 CFR 864.5260. Typical premarket route: 510(k).
How long does a 510(k) take for product code LNJ?
Across 11 cleared submissions the average was 129 days from receipt to decision (median 88).
Which companies have the most LNJ clearances?
Applied Spectral Imaging , Ltd. (2); Metasystems GmbH (1); W-Technology (1); Applied Imaging Corp. (1); Amoco Technology Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LNJ
- Run a recall and safety report across every LNJ manufacturer
- Watch product code LNJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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