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GHS — Assay, Carboxyhemoglobin Class II

FDA Device Classification

Classification Details

Product Code
GHS
Device Class
Class II
Regulation Number
864.7425
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K974805natus medicalCO-STAT(TM) END TIDAL BREATH ANALYZERMarch 11, 1998
K910827radiometer americaABL520 BLOOD GAS SYSTEMJuly 9, 1991
K790943corning medical and scientificTRISEDTA-BORATE ELECTROPHORESIS FILM AGAJune 22, 1979
K771263londonRADIOMHTER OSM-2 HEMOXIMETERAugust 3, 1977
K770209iadecECOLYZER CARBOXIMETERMarch 7, 1977