STAPHYLOCOCCUS QUICKFISH BC— 510(k) K113371

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K113371 for STAPHYLOCOCCUS QUICKFISH BC, Substantially Equivalent on 2012-04-03. 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: 2011-11-16
Decision date: 2012-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NXX

K092166 — S. AUREUS/CNS PNA FISH, MODEL KT0052009-11-23
K091827 — S. AUREUS PNA FISH2009-08-18
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

Recalls naming K113371

K-number listed on FDA's recall record

Z-2138-2014 — AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)Class II·Terminated·Advandx Inc·20140704

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113371.

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