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FDA Product Code

FDA Product Code GHS — Clearance Directory

Device Class
Class II
Assigned Panel
Hematology
21 CFR Citation
864.7425

510(k) Clearances — 5 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K974805 CO-STAT(TM) END TIDAL BREATH ANALYZER Natus Medical, Inc. 1998-03-11 Traditional PDF ↗
K910827 ABL520 BLOOD GAS SYSTEM Radiometer America, Inc. 1991-07-09 Traditional PDF ↗
K790943 TRISEDTA-BORATE ELECTROPHORESIS FILM AGA Corning Medical & Scientific 1979-06-22 Traditional PDF ↗
K771263 RADIOMHTER OSM-2 HEMOXIMETER The London Co. 1977-08-03 Traditional PDF ↗
K770209 ECOLYZER CARBOXIMETER Iadec, Inc. 1977-03-07 Traditional PDF ↗

Product code GHS · Class II · Hematology. Data: openFDA.