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RIA-Quant CK-MB Test Kit

by Mallinckrodt Critical Care 510(k)

Active United States

510(k) K792504

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792504 Date16 Jan 1980ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 5 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JHX
Device Class
Class II
Regulation
21 CFR Part 862.1215
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RIA-Quant CK-MB Test Kit is a diagnostic in vitro device designed for the quantitative measurement of creatine kinase-MB isoenzyme (CK-MB) in serum or plasma using a radioimmunoassay (RIA) method. CK-MB is a biomarker used to identify myocardial infarction (heart attack) by detecting cardiac muscle damage through elevated levels in blood samples.

This test kit is intended for use in clinical chemistry laboratories and has received FDA 510(k) clearance under the classification of Class II devices (product code JHX). Supplied as a single-use diagnostic reagent, it requires proper storage and handling as specified in the accompanying instructions. The device is regulated under FDA regulation number 862.1215 and is intended for professional use only in accredited medical settings.

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