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

Name: FDA 510(k) clearance K092166
Creator: U.S. Food and Drug Administration
Published: 2009-11-23

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.. Device class: 1.

Clearance details

Applicant: Advandx, Inc.
Product code: Code NXX
Device class: Class 1
Regulation: 21 CFR 866.3700
Advisory panel: Microbiology
Date received: 2009-07-21
Decision date: 2009-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.