Careside Ck

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K990439 ↗

FDA Product Code

JHS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Careside Amylase

  Class II

  FDA 510(k) K990025 Active Cleared 8 Feb 1999

• Careside Total Bilirubin

  Class II

  FDA 510(k) K981588 Active Cleared 23 Jun 1998

• Careside Direct Bilirubin

  Class II

  FDA 510(k) K993771 Active Cleared 27 Dec 1999

• Careside Analyzer

  Class I

  FDA 510(k) K981610 Active Cleared 25 Jun 1998

• Careside Ckmb

  Class II

  FDA 510(k) K990434 Active Cleared 19 Apr 1999

• Careside Hemoglobin

  Class II

  FDA 510(k) K001462 Active Cleared 21 Aug 2000

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