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Chlamydia Oia

by Biostar, Inc.

510(k) K951010

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK951010 Date7 Oct 1995ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0616-03 FDA Unclassified (pre-2012) initiated 7 Feb 2003
    • Terminated Z-0615-03 FDA Unclassified (pre-2012) initiated 7 Feb 2003

    Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

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  • Withdrawn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
LJC
Device Class
Class I
Regulation
21 CFR Part 866.3120
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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