Assay, Carboxyhemoglobin
Hematology · 21 CFR 864.7425
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
45 firms currently registered for this product code
Instrumentation Laboratory Co.
Bedford, MA, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Nova Biomedical Corporation
Billerica, MA, US
Nova Biomedical Corporation
WALTHAM, MA, US
Radiometer Solutions Sp. Z O.o.
Stargard Zachodniopomorskie, PL
Radiometer Sp. Z O.o
Stargard Zachodniopomorskie, PL
Diamond Diagnostics Inc.
Budapest, HU
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Radiometer Minneapolis
New Brighton, MN, US
Radiometer Medical Aps
BROENSHOEJ Hovedstaden, DK
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
510(k) clearances
5 clearances for this product code
- Natus Medical, Inc.Mar 11, 1998
K974805 · CO-STAT(TM) END TIDAL BREATH ANALYZER
- Radiometer America, Inc.Jul 9, 1991
K910827 · ABL520 BLOOD GAS SYSTEM
- Corning Medical & ScientificJun 22, 1979
K790943 · TRISEDTA-BORATE ELECTROPHORESIS FILM AGA
- The London Co.Aug 3, 1977
K771263 · RADIOMHTER OSM-2 HEMOXIMETER
- Iadec, Inc.Mar 7, 1977
K770209 · ECOLYZER CARBOXIMETER