510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820298Substantially Equivalent

Carcinoembryonic Antigen Control (4 Lev

Ventrex Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820298 is the FDA 510(k) clearance record for CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV, a class II device, cleared for Ventrex Laboratories, Inc. on under FDA product code DHX (System, Test, Carcinoembryonic Antigen). FDA records list 82 510(k) clearances for Ventrex Laboratories, Inc., from to . As of , FDA records show no recalls naming K820298.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DHX System, Test, Carcinoembryonic Antigen
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Ventrex Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DHX

Trailing 12 months

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

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