Cleared Traditional

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

K192727 · Kamiya Biomedical Company · Immunology

May 2020

Decision

236d

Days

Class 2

Risk

About This 510(k) Submission

K192727 is an FDA 510(k) clearance for the K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2), a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Kamiya Biomedical Company (Tukwila, US). The FDA issued a Cleared decision on May 20, 2020, 236 days after receiving the submission on September 27, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K192727 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2019
Decision Date	May 20, 2020
Days to Decision	236 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement