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Biotrol Ck Monoeactif

by Biotrol, USA, Inc. 510(k)

Active United States

510(k) K881267

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881267 Date16 May 1988ClearedStatusActive

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  • Withdrawn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 6 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, 21 Sep 2026

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

The Biotrol CK Monoactif is a fluorometric method device for creatine phosphokinase (CPK) or isoenzymes, classified under the Clinical Chemistry specialty. It is a Class II medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.

The device was cleared under regulation number 862.1215 with product code JHX, following a traditional 510(k) submission reviewed by the Clinical Chemistry advisory committee. It is manufactured by Biotrol, USA, Inc. and was granted clearance on May 16, 1988, after submission on March 24, 1988.

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Questions

AI-generated answers, 21 Sep 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 Biotrol CK Monoactif used for?

    The Biotrol CK Monoactif is a fluorometric method device designed to measure creatine phosphokinase (CPK) or its isoenzymes, which are enzymes used in clinical chemistry to assess tissue damage, particularly in cardiac or skeletal muscle.

  • How was the Biotrol CK Monoactif cleared for market release?

    The Biotrol CK Monoactif received FDA 510(k) clearance through a traditional submission process, demonstrating substantial equivalence to a legally marketed predicate device under regulation number 862.1215.

  • What regulatory classification does the Biotrol CK Monoactif have?

    The Biotrol CK Monoactif is classified as a Class II medical device by the FDA, based on its product code JHX and its placement within the Clinical Chemistry specialty panel.