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510(k) K242170

K-ASSAY CRP (Ver.2) by Kamiya Biomedical Company, LLC — Product Code DCK

K242170 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Company, LLC for the device "K-ASSAY CRP (Ver.2)". The FDA issued a decision of Substantially Equivalent on April 18, 2025. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2025
Date Received
July 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

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  • K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (September 24, 2015)
  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K121558 — DIAZYME HSCRP POC TEST KIT (September 21, 2012)
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FDA data resources