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FDA 510(k)

BD MAX STAPHSR ASSAY, INSTRUMENT

K-Number: K132822 · 2013-11-26

ApplicantGeneohm Sciences Canada, Inc. (Bd Diagnostics)
Decision Date2013-11-26
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX STAPHSR ASSAY, INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). It received FDA 510(k) clearance on 2013-11-26 under 510(k) number K132822. 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 STAPHSR ASSAY, INSTRUMENT?

BD MAX STAPHSR ASSAY, INSTRUMENT is a medical device that received FDA 510(k) clearance on 2013-11-26. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). The 510(k) number is K132822.

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

BD MAX STAPHSR ASSAY, INSTRUMENT received FDA 510(k) clearance on 2013-11-26, under 510(k) number K132822.

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

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

What is the FDA product code for BD MAX STAPHSR ASSAY, INSTRUMENT?

The FDA product code for BD MAX STAPHSR ASSAY, 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 Geneohm Sciences Canada, Inc. (Bd Diagnostics) as applicant

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.

K191957BD MAX Vaginal PanelK130470BD MAX CDIFF ASSAY, BD MAX INSTRUMENT

Related Devices (Code: NQX)

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.

K243625Xpert MRSA/SA SSTICepheid®K243070Xpert® SA Nasal CompleteCepheid®K191742ARIES MRSA AssayLuminex CorporationK190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheidK162444Xpert MRSA NxGCepheidK133605BD MAX MRSA XT, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc.

Official Source

View on FDA Database →

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

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