S. AUREUS/CNS PNA FISH, MODEL KT005— 510(k) K092166

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K092166 for S. AUREUS/CNS PNA FISH, MODEL KT005, Substantially Equivalent on 2009-11-23. Applicant: Advandx, Inc..

Clearance details

Applicant: Advandx, Inc.
Product code: Code NXX
Advisory panel: Microbiology
Date received: 2009-07-21
Decision date: 2009-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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