510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043519Substantially Equivalent

Ariol Her-2/Neu Fish

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

K043519 is the FDA 510(k) clearance record for ARIOL HER-2/NEU FISH, a class II device, cleared for Applied Imaging Corp. on under FDA product code NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays). FDA records list 7 510(k) clearances for Applied Imaging Corp., from to . As of , FDA records show one recall naming K043519.

Clearance record

Decision date
Received
(126 days to decision)
Product code
NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Regulation
21 CFR 866.4700
Device class
Class II
Review panel
Immunology
Applicant
Applied Imaging Corp. 120 Baytech Dr., San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code NTH

Trailing 12 months

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

FDA records show no clearances under product code NTH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTH, 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