FDA 510(k)

BD GENEOHM MRSA ACP ASSAY

K-Number: K093346 · 2009-12-15

ApplicantBd Diagnostics (Geneohm Sciences, Inc.)

Decision Date2009-12-15

Product CodeNQX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD GENEOHM MRSA ACP ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bd Diagnostics (Geneohm Sciences, Inc.). It received FDA 510(k) clearance on 2009-12-15 under 510(k) number K093346. 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 MRSA ACP ASSAY?

BD GENEOHM MRSA ACP ASSAY is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Bd Diagnostics (Geneohm Sciences, Inc.). The 510(k) number is K093346.

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

BD GENEOHM MRSA ACP ASSAY received FDA 510(k) clearance on 2009-12-15, under 510(k) number K093346.

Who is the listed applicant for BD GENEOHM MRSA ACP ASSAY?

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

What is the FDA product code for BD GENEOHM MRSA ACP ASSAY?

The FDA product code for BD GENEOHM MRSA ACP ASSAY is NQX.

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

K081920BD GENEOHM CDIFF 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.