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
K853388Substantially Equivalent

Monosticon Uni-Dot

Organon LLC, West Orange NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853388 is the FDA 510(k) clearance record for MONOSTICON UNI-DOT, a class II device, cleared for Organon, Inc. on under FDA product code KTN (System, Test, Infectious Mononucleosis). FDA records list 42 510(k) clearances for Organon, Inc., from to . As of , FDA records show no recalls naming K853388.

Clearance record

Decision date
Received
(9 days to decision)
Product code
KTN System, Test, Infectious Mononucleosis
Regulation
21 CFR 866.5640
Device class
Class II
Review panel
Immunology
Applicant
Organon, Inc.
Third party review
No

Clearances, product code KTN

Trailing 12 months

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

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