Aqueous Blood Gas Controls

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K812553 ↗

FDA Product Code

JJS

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Total Bilirubin

  Class II

  FDA 510(k) K840111 Active Cleared 19 Mar 1984

• Calibrating Solution for Abl-1 & 2

  Class II

  FDA 510(k) K831018 Active Cleared 16 Jun 1983

• Reagent for Coulter Counter Model 5+11

  Class I

  FDA 510(k) K821683 Active Cleared 24 Jun 1982

• Total Protein Reagent Cs-724

  Class II

  FDA 510(k) K833950 Active Cleared 13 Jan 1984

• Cleaning Solution For Radiometer OSM2

  Class II

  FDA 510(k) K812623 Active Cleared 2 Nov 1981

• Diagnostics Po 2 Electrolyte

  Class II

  FDA 510(k) K831013 Active Cleared 8 Jun 1983

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