Product code LNJ— Hematology
ACLAIMS-IS
- Classification name
- Analyzer, Chromosome, Automated
- Device class
- Class 2
- Regulation
- 21 CFR 864.5260
- Advisory panel
- Hematology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code LNJ
FDA has cleared devices under product code LNJ between 1985 and 2005, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 2001
- 1995
- 1991
- 1990
- 1987
- 1986
- 1985
Top applicants under product code LNJ
Recent clearances under product code LNJ
- K050236 — FISHVIEW
- K012103 — BANDVIEW SYSTEM
- K940240 — IKAROS
- K912085 — ACLAIMS-IS
- K902311 — GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.
- K895095 — AKS II
- K872755 — KARYOTEC 100
- K864955 — CYTOSCAN
- K861974 — PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST
- K851508 — NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS
- K851174 — METACHROME
Data sourced from openFDA. This site is unofficial and independent of the FDA.