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Alkaline Phosphatase Reagent System

by Medical Diagnostic Technologies, Inc.

510(k) K952746

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952746 Date27 Nov 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
CJE
Device Class
Class II
Regulation
21 CFR Part 862.1050
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 Alkaline Phosphatase Reagent System is a diagnostic reagent used in clinical chemistry for the quantitative in‑vitro determination of alkaline phosphatase activity or its isoenzymes in human serum. The system provides the necessary chemicals, including nitrophenylphosphate substrate, to generate a measurable colorimetric reaction that reflects enzyme concentration.

The reagent system was cleared by the U.S. Food and Drug Administration through a traditional 510(k) submission (K952746) and is classified as a Class II device. It is supplied by Medical Diagnostic Technologies, Inc. for use in laboratory settings, and is intended for single‑use application as part of an alkaline phosphatase assay. The product is identified by the FDA product code CJE and is listed under regulation number 862.1050.

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