Eclipse Ica Glucose

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K905144 ↗

FDA Product Code

CFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Eclipse Ica Triglycerides

  Class I

  FDA 510(k) K905601 Active Cleared 17 Jan 1991

• Eclipse Ica Digoxin

  Class II

  FDA 510(k) K905719 Active Cleared 17 Jan 1991

• Eclipse Ica Tsh

  Class II

  FDA 510(k) K910256 Active Cleared 22 Feb 1991

• Eclipse Ica Analyzer

  Class I

  FDA 510(k) K910302 Active Cleared 22 Feb 1991

• Eclipse Ica Cholesterol

  Class I

  FDA 510(k) K905145 Active Cleared 26 Feb 1991

• Eclipse Ica Bun

  Class II

  FDA 510(k) K905602 Active Cleared 16 Jan 1991