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Inplex Cf Molecular Test

by Third Wave Technologies, Inc.

510(k) K063787

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063787 Date13 Mar 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1580-2016 FDA Class II initiated 31 Mar 2016

    Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NUA
Device Class
Class II
Regulation
21 CFR Part 866.5900
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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