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Dynazyme Tm Ii Cardiak-Mb

by J.T. Baker Chemical Co. 510(k)

Active United States

510(k) K772172

Overview

DYNAZYME TM II CARDIAK-MB is a clinical chemistry device designed for the measurement of creatine kinase isoenzymes using a U.V. method. It is intended for use in diagnostic laboratories to assess cardiac muscle damage.

The device is supplied as a single-use, non-sterile product and is not MRI safe. It should be stored at room temperature and is regulated under FDA 510(k) clearance (K772172).

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK772172 Date6 Dec 1977ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

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

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