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FDA 510(k)

BD GENEOHM STAPHSR ASSAY

K-Number: K071026 · 2007-12-20

ApplicantBd Diagnostics (Geneohm Sciences Canada, Inc)
Decision Date2007-12-20
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD GENEOHM STAPHSR ASSAY 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 2007-12-20 under 510(k) number K071026. 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 GENEOHM STAPHSR ASSAY?

BD GENEOHM STAPHSR ASSAY is a medical device that received FDA 510(k) clearance on 2007-12-20. The listed applicant is Bd Diagnostics (Geneohm Sciences Canada, Inc). The 510(k) number is K071026.

When did BD GENEOHM STAPHSR ASSAY receive FDA 510(k) clearance?

BD GENEOHM STAPHSR ASSAY received FDA 510(k) clearance on 2007-12-20, under 510(k) number K071026.

Who is the listed applicant for BD GENEOHM STAPHSR ASSAY?

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 GENEOHM STAPHSR ASSAY?

The FDA product code for BD GENEOHM STAPHSR ASSAY 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K120138BD MAX MRSA 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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