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Data-Zyme CK Calorimetric/UV Procedure

by Data Medical Associates, Inc. 510(k)

Active United States

510(k) K790343

Overview

The Data-Zyme CK Calorimetric/UV Procedure is a clinical chemistry device used for the differential rate kinetic method of measuring creatine phosphokinase or isoenzymes. It functions as a diagnostic tool to assist in the analysis of enzyme activity levels within clinical laboratory settings.

This device is supplied as part of a traditional 510(k) premarket notification process and has received FDA 510(k) clearance under K790343. It is regulated under the clinical chemistry medical specialty and is classified as a class 2 medical device.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790343 Date1 May 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • 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
JHS
Device Class
Class II
Regulation
21 CFR Part 862.1215
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary function of the Data-Zyme CK Calorimetric/UV Procedure?

    This device is a clinical chemistry tool used to measure creatine phosphokinase or its isoenzymes. It utilizes a differential rate kinetic method to assist laboratory professionals in analyzing enzyme activity levels.

  • How is this device regulated?

    The Data-Zyme CK Calorimetric/UV Procedure is classified as a class 2 medical device under the clinical chemistry medical specialty. It has received FDA 510(k) clearance under K790343, confirming it was processed through a traditional premarket notification.

  • What is the regulatory classification of this device?

    The device is regulated under 21 CFR 862.1215 and is assigned the product code JHS. It was determined to be substantially equivalent to existing devices during its 1979 review process.