FDA 510(k)

TAG-IT CYSTIC FIBROSIS KIT

K-Number: K060627 · 2006-06-07

Decision Date2006-06-07

Product CodeNUA

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

TAG-IT CYSTIC FIBROSIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Tm Bioscience Corporation. It received FDA 510(k) clearance on 2006-06-07 under 510(k) number K060627. 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 TAG-IT CYSTIC FIBROSIS KIT?

TAG-IT CYSTIC FIBROSIS KIT is a medical device that received FDA 510(k) clearance on 2006-06-07. The listed applicant is Tm Bioscience Corporation. The 510(k) number is K060627.

When did TAG-IT CYSTIC FIBROSIS KIT receive FDA 510(k) clearance?

TAG-IT CYSTIC FIBROSIS KIT received FDA 510(k) clearance on 2006-06-07, under 510(k) number K060627.

Who is the listed applicant for TAG-IT CYSTIC FIBROSIS KIT?

The FDA 510(k) record lists Tm Bioscience Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TAG-IT CYSTIC FIBROSIS KIT?

The FDA product code for TAG-IT CYSTIC FIBROSIS KIT is NUA.

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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.