510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K935161Substantially Equivalent

Keratin Primary Antibody

Ventana Medical Systems Inc, Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935161 is the FDA 510(k) clearance record for KERATIN PRIMARY ANTIBODY, a class II device, cleared for Ventana Medical Systems, Inc. on under FDA product code DEH (Lambda, Antigen, Antiserum, Control). FDA records list 49 510(k) clearances for Ventana Medical Systems, Inc., from to . As of , FDA records show no recalls naming K935161.

Clearance record

Decision date
Received
(875 days to decision)
Product code
DEH Lambda, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Ventana Medical Systems, Inc. 3865 N. Business Center Dr., Tucson AZ
510(k) summary
Summary
Third party review
No

Clearances, product code DEH

Trailing 12 months

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

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