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Browne Opa Test Strip

by Steris Corporation

510(k) K081427

Browne Opa Test Strip is a Class II device made by Steris Corporation, cleared under FDA 510(k) K081427 on 11 Jun 2008, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK081427 Date11 Jun 2008ClearedStatusActive

Official records

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  • Withdrawn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
Device class
Class II
Regulation
21 CFR Part 880.2800
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K081427

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K081427
UDI-DISize and differences
CIDEX™ 20392
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
20392 / 2039220705037045553 —On the market
CIDEX™ 20393
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
20393 / 2039320705037045560 —On the market

Similar devices

Other devices filed under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process).

Other devices from Steris Corporation

See all devices from Steris Corporation →