510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131140Substantially Equivalent

Omnyx Idp for Her2 Manual Application

Omnyx, LLC, Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131140 is the FDA 510(k) clearance record for OMNYX IDP FOR HER2 MANUAL APPLICATION, a class II device, cleared for Omnyx, LLC on under FDA product code OEO (Automated Digital Image Manual Interpretation Microscope). FDA's definition for product code OEO reads: "The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic...". FDA records list one 510(k) clearance for Omnyx, LLC. As of , FDA records show no recalls naming K131140.

Clearance record

Decision date
Received
(344 days to decision)
Product code
OEO Automated Digital Image Manual Interpretation Microscope
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Omnyx, LLC 62 Forest St., Suite 300, Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEO

Trailing 12 months

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

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