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K-Assay Crp (2), K-Assay Crp Multi-Calibrator A, K-Assay Crp Multi-Calibrator B

FDA 510(k)

Class II (US FDA 510(k))

510(k) K992312

by Kamiya Biomedical Co.

Identifiers

510(k) Number
K992312 FDA 510(k)
FDA Product Code
DCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5270 FDA 510(k)
Regulation Number
866.5270 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The K-Assay CRP (2) is an in vitro diagnostic reagent kit designed for the quantitative measurement of C-Reactive Protein in human serum. It utilizes a latex particle-enhanced immunoturbidimetric assay principle to determine CRP levels.

This device is supplied with multi-calibrators A and B, which contain purified human serum. The product has received FDA 510(k) clearance under regulation number 866.5270.

Frequently asked questions

What is the K-Assay CRP (2) used for?

This device is an in vitro diagnostic reagent kit intended for the quantitative measurement of C-Reactive Protein (CRP) levels in human serum. It utilizes a latex particle-enhanced immunoturbidimetric assay principle to provide these measurements.

What components are included with this reagent kit?

The kit is supplied with the K-Assay CRP (2) reagent along with K-Assay CRP Multi-Calibrator A and K-Assay CRP Multi-Calibrator B. These calibrators are formulated using purified human serum to ensure accurate measurement results.

Has this device received regulatory clearance?

Yes, the K-Assay CRP (2) and its associated multi-calibrators have received FDA 510(k) clearance under regulation number 866.5270. This indicates that the device has been reviewed and cleared for use as an in vitro diagnostic product.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K-assay Crp (2), K-assay Crp Multi-calibrator A, K-assay Crp Multi ..., Kamiya Biomedical Company - Clinical Diagnostics - CRP Calibrator, PDF KAMIYA BIOMEDICAL COMPANY K ASSAY CRP Calibrator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kamiya Biomedical Co.

Sources (1)

  • FDA 510(k) K992312 24 fields · synced Oct 6, 2026