Total & Direct Bilirubin Procedures

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K832942 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Sandare Uric Acid Procedure

  Class I

  FDA 510(k) K812313 Active Cleared 1 Sep 1981

• Sandare Chloride Procedure

  Class II

  FDA 510(k) K792531 Active Cleared 11 Jan 1980

• Sandare Hemoglobin Controls

  Class II

  FDA 510(k) K792209 Active Cleared 4 Dec 1979

• Total Protein Procedure

  Class II

  FDA 510(k) K832169 Active Cleared 16 Aug 1983

• Sandare Nitroprusside Test Procedure

  Class I

  FDA 510(k) K810514 Active Cleared 4 Mar 1981

• Tri-Level Bilirubin Controls

  Class I

  FDA 510(k) K833898 Active Cleared 13 Jan 1984

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