510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080910Substantially Equivalent

Pathiam System for Her2/neu Immunohistochemistry Reagents & Kits

Bioimagene, Inc., Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080910 is the FDA 510(k) clearance record for PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS, a class II device, cleared for Bioimagene, Inc. 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 3 510(k) clearances for Bioimagene, Inc., from to . As of , FDA records show no recalls naming K080910.

Clearance record

Decision date
Received
(309 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
Bioimagene, Inc. 1601 S. De Anza Blvd., Cupertino CA
510(k) summary
Summary PDF
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