BD MAX MRSA XT, BD MAX INSTRUMENT— 510(k) K133605

Name: FDA 510(k) clearance K133605
Creator: U.S. Food and Drug Administration
Published: 2013-12-20

Substantially Equivalent

Geneohm Sciences Canada, Inc.

FDA 510(k) clearance K133605 for BD MAX MRSA XT, BD MAX INSTRUMENT, Substantially Equivalent on 2013-12-20. Applicant: Geneohm Sciences Canada, Inc.. Device class: 2.

Clearance details

Applicant: Geneohm Sciences Canada, Inc.
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2013-11-25
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQX

view all

K243625 — Xpert MRSA/SA SSTI2024-12-18
K243070 — Xpert® SA Nasal Complete2024-10-25
K191742 — ARIES MRSA Assay2019-09-25
K190771 — Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System2019-04-25
K162444 — Xpert MRSA NxG2016-11-23

More clearances from Geneohm Sciences Canada, Inc.

view all

K061686 — IDI-VANR ASSAY2006-08-30

Recalls naming K133605

K-number listed on FDA's recall record

Z-2334-2019 — Kit BD Max MRSA XT; Catalog # 443461Class II·Terminated·Becton Dickinson & Co.·20190717

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133605.

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