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
K963318Substantially Equivalent

Legionella Igg/igm Elisa Test System

Armkel, LLC, Frederick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963318 is the FDA 510(k) clearance record for LEGIONELLA IGG/IGM ELISA TEST SYSTEM, a class II device, cleared for Armkel, LLC on under FDA product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent). FDA records list 68 510(k) clearances for Armkel, LLC, from to . As of , FDA records show no recalls naming K963318.

Clearance record

Decision date
Received
(192 days to decision)
Product code
LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Regulation
21 CFR 866.3300
Device class
Class II
Review panel
Microbiology
Applicant
Armkel, LLC 1306f Bailes Ln., Frederick MD
510(k) summary
Summary
Third party review
No

Clearances, product code LHL

Trailing 12 months

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

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