LNJ — Analyzer, Chromosome, Automated Class II
FDA product code LNJ covers "Analyzer, Chromosome, Automated", a Class II medical device regulated under 21 CFR 864.5260. Submissions are reviewed by the Hematology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LNJ
- Device Class
- Class II
- Regulation Number
- 864.5260
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050236 | applied spectral imaging | FISHVIEW | June 27, 2005 |
| K012103 | applied spectral imaging | BANDVIEW SYSTEM | September 14, 2001 |
| K940240 | metasystems | IKAROS | February 24, 1995 |
| K912085 | w-technology | ACLAIMS-IS | October 31, 1991 |
| K902311 | applied imaging | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | August 20, 1990 |
| K895095 | amoco technology | AKS II | February 9, 1990 |
| K872755 | amcor electronics | KARYOTEC 100 | September 1, 1987 |
| K864955 | image recognition systems | CYTOSCAN | March 16, 1987 |
| K861974 | perceptive systems | PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST | August 4, 1986 |
| K851508 | nikon | NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS | July 12, 1985 |
| K851174 | potomac medical system | METACHROME | May 23, 1985 |