S. AUREUS PNA FISH— 510(k) K091827

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K091827 for S. AUREUS PNA FISH, Substantially Equivalent on 2009-08-18. 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: 2009-06-19
Decision date: 2009-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NXX

K113371 — STAPHYLOCOCCUS QUICKFISH BC2012-04-03
K092166 — S. AUREUS/CNS PNA FISH, MODEL KT0052009-11-23
K060099 — S. AUREUS PNA FISH2006-05-08

More clearances from Advandx, Inc.

K140619 — MECA XPRESSFISH2014-10-10
K123418 — GRAM-NEGATIVE QUICKFISH BC2013-07-21
K121991 — ENTEROCOCCUS QUICKFISH BC2013-01-07
K101558 — GNR TRAFFIC LIGHT PNA FISH2010-12-16
K093024 — YEAST TRAFFIC LIGHT PNA FISH2010-07-15

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