I-Estriol Test Set

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K781599 ↗

FDA Product Code

CGI

Device Class

Class I

Regulation

21 CFR Part 862.1265

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• 17-Hydroxyprogesterone Test Set

  Class I

  FDA 510(k) K771729 Active Cleared 21 Oct 1977

• 125I-Testosterone Test Set

  Class I

  FDA 510(k) K802728 Active Cleared 11 Dec 1980

• Androstenedione Test Set 125I

  Class I

  FDA 510(k) K832452 Active Cleared 12 Sep 1983

• Shbg

  Class I

  FDA 510(k) K912850 Active Cleared 12 Aug 1991

• Progesterone Test Set 125I 17-Oh

  Class I

  FDA 510(k) K834246 Active Cleared 4 Feb 1984

• 125I Digoxin Test Set

  Class II

  FDA 510(k) K772306 Active Cleared 22 Dec 1977

See all devices from Wien Laboratories, Inc. →