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Toxcup Drug Screen Cup

by Branan Medical Corp. 510(k)

Active United States

510(k) K122633

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122633 Date7 Feb 2013ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-3047-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3033-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3032-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3040-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3031-2020 FDA Class II initiated 18 Aug 2020 via K122633, on the same 510(k)
    • Terminated Z-3035-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3039-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3045-2020 FDA Class II initiated 18 Aug 2020 via K122633, on the same 510(k)

    Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
LDJ
Device Class
Class II
Regulation
21 CFR Part 862.3870
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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