Radiometer Acid Base Laboratory-Abl-3

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K800224 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Qualicheck Tm

  Class I

  FDA 510(k) K771444 Active Cleared 16 Aug 1977

• ICA1 Ionized Calcium Analyzer

  Class II

  FDA 510(k) K801848 Active Cleared 31 Oct 1980

• Radiomhter Osm-2 Hemoximeter

  Class II

  FDA 510(k) K771263 Active Cleared 3 Aug 1977

• Hemoglobin Check Solutions, S2100 Osm-2

  Class I

  FDA 510(k) K780652 Active Cleared 27 Jul 1978

• TCM202 TCPO2 & TCM204 TCPO2/PO2 Rec. Sy.

  Class II

  FDA 510(k) K802846 Active Cleared 17 Dec 1980

• Acid Base System, Radiometer Automated

  Class II

  FDA 510(k) K760229 Active Cleared 26 Aug 1976