FDA.reportPublic FDA data

Device Listing 1809311044

Listing Summary#

Listing key
1809311044
Premarket submission
K192727
Device
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
Applicant
Kamiya Biomedical Company
Product code
DHR
Decision date
2020-05-20