ENTEROCOCCUS FAECALIS PNA FISH— 510(k) K063127

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K063127 for ENTEROCOCCUS FAECALIS PNA FISH, Substantially Equivalent on 2006-12-22. Applicant: Advandx, Inc.. Device class: 1.

Clearance details

Applicant: Advandx, Inc.
Product code: Code OAH
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2006-10-13
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAH

K121991 — ENTEROCOCCUS QUICKFISH BC2013-01-07
K083074 — AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT2009-07-24
K082612 — GBS PNA FISH2009-05-05

More clearances from Advandx, Inc.

K140619 — MECA XPRESSFISH2014-10-10
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K113371 — STAPHYLOCOCCUS QUICKFISH BC2012-04-03
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.