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Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use); (for Professional); (for Home T

by Tianjin New Bay Bioresearch Co., Ltd.

510(k) K073431

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK073431 Date14 Jan 2008ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2106-2011 FDA Unclassified (pre-2012) initiated 21 Mar 2011
    • Terminated Z-2107-2011 FDA Unclassified (pre-2012) initiated 21 Mar 2011

    Potential for false negatives test results and negative/faint positive controls

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  • Withdrawn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
KHE
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 864.6550
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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