Bioclone's Elegance Hcg Elisa Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K910420 ↗

FDA Product Code

JHI

FDA applicant

Bioclone Australia Pty , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Elegance Gh Elisa

  Class I

  FDA 510(k) K905098 Active Cleared 6 Dec 1990

• Bioclones Elegance Fsh Elisa Kit

  Class I

  FDA 510(k) K904405 Active Cleared 26 Oct 1990

• Elegance FT4 Elisa

  Class II

  FDA 510(k) K922284 Active Cleared 10 Jul 1992

• Bioclone's Elegance Ige Elisa Kit

  Class II

  FDA 510(k) K910419 Active Cleared 21 Jun 1991

• Elegance Neonatal Tsh Elisa

  Class II

  FDA 510(k) K935049 Active Cleared 3 Oct 1994

• Elegance Prolactin Elisa

  Class I

  FDA 510(k) K904483 Active Cleared 5 Nov 1990

See all devices from Bioclone Australia Pty, Ltd. →