Kemble 405

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

510(k) Number

K842894 ↗

FDA Product Code

JQW

Device Class

Class I

Regulation

21 CFR Part 862.2750

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Kemtek 400 Ria Gamma Counter

  Class I

  FDA 510(k) K832734 Active Cleared 14 Oct 1983

• Kemtek 104 Ria Gamma Counter

  Class I

  FDA 510(k) K832736 Active Cleared 29 Sep 1983

• Ria Software

  Class I

  FDA 510(k) K832760 Active Cleared 14 Oct 1983

• Immu-Count

  Class I

  FDA 510(k) K820137 Active Cleared 5 Feb 1982

• Thyro-Count Thyroid Uptake System 90IZD Probe

  Not classified

  FDA 510(k) K827748 Active Cleared 16 Aug 1982

• Kemtek 103 Ria Gamma Counter

  Class I

  FDA 510(k) K832735 Active Cleared 29 Sep 1983

See all devices from Kemble Instruments, Inc. →