K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
K-Number: K192727 · 2020-05-20
ApplicantKamiya Biomedical Company
Decision Date2020-05-20
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is a medical device manufactured by Kamiya Biomedical Company. It received FDA 510(k) clearance on 2020-05-20 under approval number K192727. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is a medical device that received FDA 510(k) clearance on 2020-05-20. It is manufactured by Kamiya Biomedical Company. The 510(k) number is K192727.
When was K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) approved by the FDA?
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) received FDA 510(k) clearance on 2020-05-20, under approval number K192727.
What company makes K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is manufactured by Kamiya Biomedical Company.
What is the FDA product code for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?
The FDA product code for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is DHR.
Related Devices (Code: DHR)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.