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Breathtek - Ubit Ubt for H. Pylori

by Meretek Diagnostics, Inc.

510(k) K014225

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 · Special NumberK014225 Date17 Jan 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0003-2008 FDA Unclassified (pre-2012) initiated 2 May 2007

    Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

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  • Withdrawn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
MSQ
Device Class
Class I
Regulation
21 CFR Part 866.3110
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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