V-Trend Im Dry-Spot Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K880399 ↗

FDA Product Code

KTN

Device Class

Class II

Regulation

21 CFR Part 866.5640

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• First Sign

  Class II

  FDA 510(k) K973208 Active Cleared 20 Oct 1997

• V-Trend Qc Tdm Control Serum 1, 2, 3.

  Class I

  FDA 510(k) K862817 Active Cleared 19 Aug 1986

• Count-10 Trol

  Class I

  FDA 510(k) K822540 Active Cleared 8 Oct 1982

• V-Trend Strep a Test

  Class I

  FDA 510(k) K880483 Active Cleared 12 Apr 1988

• Sero/Tex Le Test

  Class II

  FDA 510(k) K821385 Active Cleared 28 May 1982

• Target Myoglobin Test

  Class II

  FDA 510(k) K963680 Active Cleared 6 Feb 1997

See all devices from Texas Immunology, Inc. →