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FDA 510(k)

INPLEX CF MOLECULAR TEST

K-Number: K063787 · 2008-03-13

ApplicantThird Wave Technologies, Inc.
Decision Date2008-03-13
Product CodeNUA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

INPLEX CF MOLECULAR TEST 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 2008-03-13 under 510(k) number K063787. 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 INPLEX CF MOLECULAR TEST?

INPLEX CF MOLECULAR TEST is a medical device that received FDA 510(k) clearance on 2008-03-13. The listed applicant is Third Wave Technologies, Inc.. The 510(k) number is K063787.

When did INPLEX CF MOLECULAR TEST receive FDA 510(k) clearance?

INPLEX CF MOLECULAR TEST received FDA 510(k) clearance on 2008-03-13, under 510(k) number K063787.

Who is the listed applicant for INPLEX CF MOLECULAR TEST?

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 INPLEX CF MOLECULAR TEST?

The FDA product code for INPLEX CF MOLECULAR TEST is NUA.

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Other records listing Third Wave Technologies, Inc. as applicant

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Official Source

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