510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070522Substantially Equivalent

Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012

Abbott Diagnostics Scarborough, Inc., Scarborough ME / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070522 is the FDA 510(k) clearance record for MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012, a class II device, cleared for Inverness Medical Professional Diagnostics on under FDA product code MJH (Legionella, Spp., Elisa). FDA records list 7 510(k) clearances for Abbott Diagnostics Scarborough, Inc., from to . As of , FDA records show no recalls naming K070522.

Clearance record

Decision date
Received
(20 days to decision)
Product code
MJH Legionella, Spp., Elisa
Regulation
21 CFR 866.3300
Device class
Class II
Review panel
Microbiology
Applicant
Inverness Medical Professional Diagnostics 10 Southgate Rd., Scarborough ME
510(k) summary
Summary PDF
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