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Forsure One Step Fecal Occult Blood (Fob) Screen Card Test

by New Bay Bioresearch Co., Ltd.

510(k) K063693

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK063693 Date11 May 2007ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2108-2011 FDA Unclassified (pre-2012) initiated 21 Mar 2011
    • Terminated Z-2109-2011 FDA Unclassified (pre-2012) initiated 21 Mar 2011
    • Terminated Z-2111-2011 FDA Unclassified (pre-2012) initiated 21 Mar 2011
    • Terminated Z-2110-2011 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  • Withdrawn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
FDA applicant
New Bay Bioresearch Co. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 864.6550
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent