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Strep a Oia Max

by Biostar, Inc.

510(k) K962060

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962060 Date23 Jul 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1506-2009 FDA Unclassified (pre-2012) initiated 6 Apr 2009

    Potential for false positive Strep A results.

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  • Withdrawn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
GTZ
Device Class
Class I
Regulation
21 CFR Part 866.3740
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Biostar, Inc.

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    Class I

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    Class I

  • Ab Flu Oia

    Class II

  • Cdtox a Oia

    Class I

  • Strep B Oia

    Class I