FDA 510(k)

BD MAX MRSA ASSAY, BD MAX INSTRUMENT

K-Number: K120138 · 2012-07-05

ApplicantBd Diagnostics (Geneohm Sciences Canada, Inc)

Decision Date2012-07-05

Product CodeNQX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD MAX MRSA ASSAY, BD MAX INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Bd Diagnostics (Geneohm Sciences Canada, Inc). It received FDA 510(k) clearance on 2012-07-05 under 510(k) number K120138. 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 ASSAY, BD MAX INSTRUMENT?

BD MAX MRSA ASSAY, BD MAX INSTRUMENT is a medical device that received FDA 510(k) clearance on 2012-07-05. The listed applicant is Bd Diagnostics (Geneohm Sciences Canada, Inc). The 510(k) number is K120138.

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

BD MAX MRSA ASSAY, BD MAX INSTRUMENT received FDA 510(k) clearance on 2012-07-05, under 510(k) number K120138.

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

The FDA 510(k) record lists Bd Diagnostics (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 ASSAY, BD MAX INSTRUMENT?

The FDA product code for BD MAX MRSA ASSAY, 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.

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Other records listing Bd Diagnostics (Geneohm Sciences Canada, Inc) as applicant

K071026BD GENEOHM STAPHSR 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 K133605BD MAX MRSA XT, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc.

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.