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FDA 510(k)

IDI-MRSA ASSAY

K-Number: K042357 · 2004-10-22

ApplicantInfectio Diagnostic (I.D.I.), Inc.
Decision Date2004-10-22
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDI-MRSA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Infectio Diagnostic (I.D.I.), Inc.. It received FDA 510(k) clearance on 2004-10-22 under 510(k) number K042357. 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 IDI-MRSA ASSAY?

IDI-MRSA ASSAY is a medical device that received FDA 510(k) clearance on 2004-10-22. The listed applicant is Infectio Diagnostic (I.D.I.), Inc.. The 510(k) number is K042357.

When did IDI-MRSA ASSAY receive FDA 510(k) clearance?

IDI-MRSA ASSAY received FDA 510(k) clearance on 2004-10-22, under 510(k) number K042357.

Who is the listed applicant for IDI-MRSA ASSAY?

The FDA 510(k) record lists Infectio Diagnostic (I.D.I.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDI-MRSA ASSAY?

The FDA product code for IDI-MRSA 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.

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Other records listing Infectio Diagnostic (I.D.I.), 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.

K033415IDI-MRSA

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

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

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