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Tandem Icon QSR CKMB Immunoenzymetric Assay

by Hybritech, Inc. 2 variants

510(k) K921763

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921763 Date9 Jun 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JHY
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 Tandem Icon QSR CKMB Immunoenzymetric Assay is a colorimetric method for measuring CK-MB isoenzymes in clinical chemistry. It is designed for the quantitative determination of creatine kinase-MB (CK-MB) in human serum or plasma using an immunoenzymetric assay format.

This in vitro diagnostic device is supplied as a reagent kit for use in clinical laboratories. It is intended for professional use only and requires appropriate laboratory instrumentation for processing. The device has received FDA 510(k) clearance (K921763) and is classified as a Class II medical device under regulation 862.1215 with product code JHY.

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Questions

AI-generated answers, 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.

  • What is the Tandem Icon QSR CKMB Immunoenzymetric Assay used for?

    It is used for the quantitative determination of creatine kinase-MB (CK-MB) isoenzymes in human serum or plasma using an immunoenzymetric assay format, aiding in the assessment of cardiac muscle damage.

  • How is the Tandem Icon QSR CKMB Immunoenzymetric Assay supplied and what is required for its use?

    It is supplied as a reagent kit for in vitro diagnostic use in clinical laboratories and requires appropriate laboratory instrumentation for processing, intended for professional use only.

  • Is the Tandem Icon QSR CKMB Immunoenzymetric Assay reusable or single-use?

    As a reagent kit designed for clinical chemistry testing, it is intended for single-use in individual test runs, with reagents consumed during the assay process and not suitable for reuse.