FDA 510(k)

BD MAX MRSA XT, BD MAX INSTRUMENT

K-Number: K133605 · 2013-12-20

Decision Date2013-12-20

Product CodeNQX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD MAX MRSA XT, BD MAX INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K133605. The device is classified under product code NQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD MAX MRSA XT, BD MAX INSTRUMENT?

BD MAX MRSA XT, BD MAX INSTRUMENT is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Geneohm Sciences Canada, Inc.. The 510(k) number is K133605.

When did BD MAX MRSA XT, BD MAX INSTRUMENT receive FDA 510(k) clearance?

BD MAX MRSA XT, BD MAX INSTRUMENT received FDA 510(k) clearance on 2013-12-20, under 510(k) number K133605.

Who is the listed applicant for BD MAX MRSA XT, BD MAX INSTRUMENT?

The FDA 510(k) record lists Geneohm Sciences Canada, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX MRSA XT, BD MAX INSTRUMENT?

The FDA product code for BD MAX MRSA XT, BD MAX INSTRUMENT is NQX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Geneohm Sciences Canada, Inc. as applicant

K061686IDI-VANR ASSAY

Related Devices (Code: NQX)

K243625Xpert MRSA/SA SSTICepheid®K243070Xpert® SA Nasal CompleteCepheid®K191742ARIES MRSA AssayLuminex Corporation K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheid K162444Xpert MRSA NxGCepheid K132822BD MAX STAPHSR ASSAY, INSTRUMENTGeneohm Sciences Canada, Inc. (Bd Diagnostics)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.