Immunocard Hcg One Step (I-S) Test Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K911826 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Immunocard(Tm) Hcg II Test Kit

  Class II

  FDA 510(k) K881709 Active Cleared 8 Jul 1988

• Modified Ddi Serocard Toxoplasma Igg Test Kit

  Class II

  FDA 510(k) K884249 Active Cleared 10 Apr 1989

• Immunocard Hcg II-S Test Kit

  Class II

  FDA 510(k) K895912 Active Cleared 1 Dec 1989

• Modified Ddi Serocard Cmv Igg Test Kit

  Class II

  FDA 510(k) K884248 Active Cleared 10 Apr 1989

• Immunocard Strep a Test

  Class I

  FDA 510(k) K896109 Active Cleared 29 Nov 1989

• Modified Ddi Serocard Rubella Igg Test Kit

  Class II

  FDA 510(k) K884247 Active Cleared 10 Apr 1989

See all devices from Disease Detection International, Inc. →