Careside Analyzer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K982118 ↗

FDA Product Code

CHH

Device Class

Class I

Regulation

21 CFR Part 862.1175

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• CareSide Glucose

  Class II

  FDA 510(k) K981183 Active Cleared 7 May 1998

• Careside Total Protein

  Class II

  FDA 510(k) K980042 Active Cleared 4 Feb 1998

• Careside Albumin

  Class II

  FDA 510(k) K980041 Active Cleared 4 Feb 1998

• Careside Creatinine

  Class II

  FDA 510(k) K980043 Active Cleared 30 Mar 1998

• Careside Bun

  Class II

  FDA 510(k) K980057 Active Cleared 5 Feb 1998

• Careside Hdl-Cholesterol

  Class I

  FDA 510(k) K981899 Active Cleared 14 Jul 1998

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