Precise Tm Hcg for Use in the Physicians Office La

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

510(k) Number

K915200 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Iq TT4 Assay

  Class II

  FDA 510(k) K931295 Active Cleared 20 Jul 1993

• Precise HCG

  Class II

  FDA 510(k) K915197 Active Cleared 17 Dec 1991

• Precise Strep a

  Class I

  FDA 510(k) K923673 Active Cleared 28 Sep 1992

• Iq Tuptake Assay

  Class II

  FDA 510(k) K931294 Active Cleared 22 Jul 1993

• Becton Dickinson Thyroid Stimulating Hormone Syste

  Class II

  FDA 510(k) K925132 Active Cleared 28 Dec 1992

• Iq Immunochemistry Sistem; Iq Tsh Assay

  Class I

  FDA 510(k) K923060 Active Cleared 15 Sep 1992

See all devices from Becton Dickinson Advanced Diagnostics →