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FDA 510(k)

XTAG CF60 KIT V2

K-Number: K083845 · 2009-12-11

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2009-12-11
Product CodeNUA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

XTAG CF60 KIT V2 is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2009-12-11 under 510(k) number K083845. The device is classified under product code NUA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTAG CF60 KIT V2?

XTAG CF60 KIT V2 is a medical device that received FDA 510(k) clearance on 2009-12-11. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K083845.

When did XTAG CF60 KIT V2 receive FDA 510(k) clearance?

XTAG CF60 KIT V2 received FDA 510(k) clearance on 2009-12-11, under 510(k) number K083845.

Who is the listed applicant for XTAG CF60 KIT V2?

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

What is the FDA product code for XTAG CF60 KIT V2?

The FDA product code for XTAG CF60 KIT V2 is NUA.

Other records listing Luminex Molecular Diagnostics, 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.

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Related Devices (Code: NUA)

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.

K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRLuminex Molecular Diagnostics, Inc.K163347xTAG Cystic Fibrosis 39 Kit v2Luminex Molecular Diagnostics, Inc.K083846XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267Luminex Molecular Diagnostics, Inc.K083294VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TESTNanosphere, Inc.K090901ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8Osmetech Molecular DiagnosticsK063787INPLEX CF MOLECULAR TESTThird Wave Technologies, 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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