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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Company. It received FDA 510(k) clearance on 2020-05-20 under 510(k) 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. The listed applicant is Kamiya Biomedical Company. The 510(k) number is K192727.

When did K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) receive FDA 510(k) clearance?

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) received FDA 510(k) clearance on 2020-05-20, under 510(k) number K192727.

Who is the listed applicant for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?

The FDA 510(k) record lists Kamiya Biomedical Company as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Kamiya Biomedical Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242170K-ASSAY CRP (Ver.2)

Related Devices (Code: DHR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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