FDA 510(k)

XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267

K-Number: K083846 · 2009-09-01

ApplicantLuminex Molecular Diagnostics, Inc.

Decision Date2009-09-01

Product CodeNUA

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 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 2009-09-01 under 510(k) number K083846. 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 CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267?

XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 is a medical device that received FDA 510(k) clearance on 2009-09-01. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K083846.

When did XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 receive FDA 510(k) clearance?

XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 received FDA 510(k) clearance on 2009-09-01, under 510(k) number K083846.

Who is the listed applicant for XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267?

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 CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267?

The FDA product code for XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 is NUA.

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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.