KQIClass II
Assay, Fetal Hemoglobin
Hematology · 21 CFR 864.7455
MDR events0All time
Recalls0All time
Registered firms13Currently listed
510(k) clearances4All time
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
13 firms currently registered for this product code
Nova Biomedical Corporation
WALTHAM, MA, US
Radiometer Solutions Sp. Z O.o.
Stargard Zachodniopomorskie, PL
Radiometer Medical Aps
BROENSHOEJ Hovedstaden, DK
Radiometer Sp. Z O.o
Stargard Zachodniopomorskie, PL
Nova Biomedical Corporation
Billerica, MA, US
Diamond Diagnostics Inc.
Budapest, HU
Sebia
EVRY Essonne, FR
510(k) clearances
4 clearances for this product code