510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902311Substantially Equivalent

Genevision - Computer Assisted Chromosome Karyo.

Applied Imaging Corp., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902311 is the FDA 510(k) clearance record for GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO., a class II device, cleared for Applied Imaging Corp. on under FDA product code LNJ (Analyzer, Chromosome, Automated). FDA records list 7 510(k) clearances for Applied Imaging Corp., from to . As of , FDA records show no recalls naming K902311.

Clearance record

Decision date
Received
(89 days to decision)
Product code
LNJ Analyzer, Chromosome, Automated
Regulation
21 CFR 864.5260
Device class
Class II
Review panel
Hematology
Applicant
Applied Imaging Corp. 2340a Walsh Ave., Santa Clara CA
Third party review
No

Clearances, product code LNJ

Trailing 12 months

FDA records hold no clearances under product code LNJ in the trailing twelve months.

FDA records show no clearances under product code LNJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LNJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260