510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031715Substantially Equivalent

Ariol Her-2/Neu Ihc

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

K031715 is the FDA 510(k) clearance record for ARIOL HER-2/NEU IHC, a class II device, cleared for Applied Imaging Corp. on under FDA product code NOT (Microscope, Automated, Image Analysis, Operator Intervention). FDA's definition for product code NOT reads: "Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention". FDA records list 7 510(k) clearances for Applied Imaging Corp., from to . As of , FDA records show one recall naming K031715.

Clearance record

Decision date
Received
(220 days to decision)
Product code
NOT Microscope, Automated, Image Analysis, Operator Intervention
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Applied Imaging Corp. 2380 Walsh Ave., Bldg.B, Santa Clara CA
510(k) summary
Statement
Third party review
No

Clearances, product code NOT

Trailing 12 months
1 clearance under product code NOT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NOT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260