Cleared Special

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

K070522 · Inverness Medical Professional Diagnostics · Microbiology

Mar 2007

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K070522 is an FDA 510(k) clearance for the MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012, a Legionella, Spp., Elisa (Class II — Special Controls, product code MJH), submitted by Inverness Medical Professional Diagnostics (Scarborough, US). The FDA issued a Cleared decision on March 15, 2007, 20 days after receiving the submission on February 23, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K070522 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2007
Decision Date	March 15, 2007
Days to Decision	20 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF