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Modification to Myallergy Test

by Immunetech Corporation

510(k) K061979

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK061979 Date22 Sep 2006ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0290-2012 FDA Unclassified (pre-2012) initiated 4 Nov 2011
    • Terminated Z-0287-2012 FDA Unclassified (pre-2012) initiated 4 Nov 2011
    • Terminated Z-0288-2012 FDA Unclassified (pre-2012) initiated 4 Nov 2011
    • Terminated Z-0289-2012 FDA Unclassified (pre-2012) initiated 4 Nov 2011
    • Terminated Z-0291-2012 FDA Unclassified (pre-2012) initiated 4 Nov 2011
    • Terminated Z-0286-2012 FDA Unclassified (pre-2012) initiated 4 Nov 2011

    ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination.

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  • Withdrawn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
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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