BINAX LEGIONELLA URINARY ANTIGEN EIA— 510(k) K934965

Name: FDA 510(k) clearance K934965
Creator: U.S. Food and Drug Administration
Published: 1994-09-20

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K934965 for BINAX LEGIONELLA URINARY ANTIGEN EIA, Substantially Equivalent on 1994-09-20. Applicant: Binax, Inc.. Device class: 2.

Clearance details

Applicant: Binax, Inc.
Product code: Code MJH
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Date received: 1993-10-15
Decision date: 1994-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

Download summary PDF View on FDA.gov ↗

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