K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)— 510(k) K192727

Name: FDA 510(k) clearance K192727
Creator: U.S. Food and Drug Administration
Published: 2020-05-20

Substantially Equivalent

Kamiya Biomedical Company

FDA 510(k) clearance K192727 for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2), Substantially Equivalent on 2020-05-20. Applicant: Kamiya Biomedical Company. Device class: 2.

Clearance details

Applicant: Kamiya Biomedical Company
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 2019-09-27
Decision date: 2020-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tukwila, WA, US

Download summary PDF View on FDA.gov ↗

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