GRAM-NEGATIVE QUICKFISH BC— 510(k) K123418

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K123418 for GRAM-NEGATIVE QUICKFISH BC, Substantially Equivalent on 2013-07-21. 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: 2012-11-06
Decision date: 2013-07-21
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
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
K082068 — E. COLI PNA FISH2009-06-25

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

Recalls naming K123418

K-number listed on FDA's recall record

Z-0619-2014 — AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood culturesClass III·Terminated·AdvanDx, Inc.·20131211

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123418.

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