510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982238Substantially Equivalent

Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522

Binax, Inc., Portland ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982238 is the FDA 510(k) clearance record for BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522, a class II device, cleared for Binax, Inc. on under FDA product code MJH (Legionella, Spp., Elisa). FDA records list 11 510(k) clearances for Binax, Inc., from to . As of , FDA records show one recall naming K982238.

Clearance record

Decision date
Received
(57 days to decision)
Product code
MJH Legionella, Spp., Elisa
Regulation
21 CFR 866.3300
Device class
Class II
Review panel
Microbiology
Applicant
Binax, Inc. 217 Read St., Portland ME
510(k) summary
Summary
Third party review
No

Clearances, product code MJH

Trailing 12 months

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

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