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Browne Ga Indicator Use in 2% Activ Glutaraldehyde

by Board of Directors, Albert Browne, Ltd.

510(k) K922481

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922481 Date2 Jun 1994ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1480-04 FDA Unclassified (pre-2012) initiated 4 Sep 2003

    Performance failure complaints.

    • Terminated Z-0712-03 FDA Unclassified (pre-2012) initiated 25 Feb 2003

    Moisture ingress into packaging of test strips may cause premature failure.

    • Terminated Z-0694-03 FDA Unclassified (pre-2012) initiated 14 Feb 2003 on shared 510(k) K922481

    Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
JOJ
FDA applicant
Board of Directors, Albert Browne , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.2800
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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