EK/P. AERUGINOSA PNA FISH— 510(k) K081433

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K081433 for EK/P. AERUGINOSA PNA FISH, Substantially Equivalent on 2009-03-26. Applicant: Advandx, Inc..

Clearance details

Applicant: Advandx, Inc.
Product code: Code JSS
Advisory panel: Microbiology
Date received: 2008-05-21
Decision date: 2009-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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