LNJ
11 FDA 510(k) clearances · Product code
88 daysmedian time to decision
179 days90th percentile
11clearances measured
FDA profile
- Official device name
- Analyzer, Chromosome, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5260
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FISHVIEW (K050236) | Applied Spectral Imaging , Ltd. | 2005-06-27 |
| BANDVIEW SYSTEM (K012103) | Applied Spectral Imaging , Ltd. | 2001-09-14 |
| IKAROS (K940240) | Metasystems GmbH | 1995-02-24 |
| ACLAIMS-IS (K912085) | W-Technology | 1991-10-31 |
| GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. (K902311) | Applied Imaging Corp. | 1990-08-20 |
| AKS II (K895095) | Amoco Technology Co. | 1990-02-09 |
| KARYOTEC 100 (K872755) | Amcor Electronics, Ltd. | 1987-09-01 |
| CYTOSCAN (K864955) | Image Recognition Systems , Ltd. | 1987-03-16 |
| PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST (K861974) | Perceptive Systems, Inc. | 1986-08-04 |
| NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS (K851508) | Nikon, Inc. | 1985-07-12 |
| METACHROME (K851174) | Potomac Medical System | 1985-05-23 |
Track LNJ automatically
Every clearance here is in the API, with alerts when new ones post.