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FDA 510(k)

INVADER UGT1A1 MOLECULAR ASSAY

K-Number: K051824 · 2005-08-18

ApplicantThird Wave Technologies, Inc.
Decision Date2005-08-18
Product CodeNTI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INVADER UGT1A1 MOLECULAR ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Third Wave Technologies, Inc.. It received FDA 510(k) clearance on 2005-08-18 under 510(k) number K051824. The device is classified under product code NTI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVADER UGT1A1 MOLECULAR ASSAY?

INVADER UGT1A1 MOLECULAR ASSAY is a medical device that received FDA 510(k) clearance on 2005-08-18. The listed applicant is Third Wave Technologies, Inc.. The 510(k) number is K051824.

When did INVADER UGT1A1 MOLECULAR ASSAY receive FDA 510(k) clearance?

INVADER UGT1A1 MOLECULAR ASSAY received FDA 510(k) clearance on 2005-08-18, under 510(k) number K051824.

Who is the listed applicant for INVADER UGT1A1 MOLECULAR ASSAY?

The FDA 510(k) record lists Third Wave Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INVADER UGT1A1 MOLECULAR ASSAY?

The FDA product code for INVADER UGT1A1 MOLECULAR ASSAY is NTI.

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Other records listing Third Wave Technologies, Inc. as applicant

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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.

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