FDA.reportPublic FDA data

510(k) K242170

Device
K-ASSAY CRP (Ver.2)
Applicant
Kamiya Biomedical Company, LLC
510(k) number
K242170
Product code
DCK
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-18
Date received
2024-07-24
Regulation
866.5270
Classification name
C-Reactive Protein, Antigen, Antiserum, And Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shawn Kaplan
Address
12779 Gateway Dr. S Tukwila WA US 98168 98168

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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