E.COLI/P. AERUGINOSA PNA FISH— 510(k) K081309

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K081309 for E.COLI/P. AERUGINOSA PNA FISH, Substantially Equivalent on 2008-12-19. Applicant: Advandx, Inc.. Device class: 1.

Clearance details

Applicant: Advandx, Inc.
Product code: Code JSS
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2008-05-09
Decision date: 2008-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSS

K150031 — hemoFISH Masterpanel2015-10-01
K123418 — GRAM-NEGATIVE QUICKFISH BC2013-07-21
K101558 — GNR TRAFFIC LIGHT PNA FISH2010-12-16
K092236 — E.COLI/P. AERUGINOSA PNA FISH2009-12-16
K092393 — EK/P. AERUGINOSA PNA FISH2009-09-01

More clearances from Advandx, Inc.

K140619 — MECA XPRESSFISH2014-10-10
K121991 — ENTEROCOCCUS QUICKFISH BC2013-01-07
K113371 — STAPHYLOCOCCUS QUICKFISH BC2012-04-03
K093024 — YEAST TRAFFIC LIGHT PNA FISH2010-07-15
K092784 — C. ALBICANS/C. GLABRATA PNA FISH2010-03-12

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