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Alkaline Phosph., Liquid Enzy., Kin. Kit

by Bio-Analytics Laboratories, Inc. 510(k)

Active United States

510(k) K810082

Overview

Alkaline Phosphatase Liquid Enzyme Kinetic Kit is a device used in clinical chemistry for the measurement of alkaline phosphatase activity. It is a reagent kit designed for in vitro diagnostic use to quantify alkaline phosphatase or its isoenzymes in biological samples.

The kit is supplied as a liquid enzyme reagent system and is intended for use in clinical laboratory settings. It is classified as a Class II medical device under FDA regulation 862.1050 and received traditional 510(k) clearance as substantially equivalent to a predicate device. The device is not described as sterile, single-use, reusable, or MRI-safe in the provided data, and no storage conditions or size specifications are included.

AI-generated from registry data, 23 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 NumberK810082 Date26 Jan 1981ClearedStatusActive

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 22 Oct 2026.

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

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Questions

  • What is the ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT used for?

    The ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT is used in clinical chemistry for the measurement of alkaline phosphatase activity. It is a reagent kit designed for in vitro diagnostic use to quantify alkaline phosphatase or its isoenzymes in biological samples.

  • How is the ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT supplied?

    The kit is supplied as a liquid enzyme reagent system and is intended for use in clinical laboratory settings.

  • Is the ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT sterile or single-use?

    The device is not described as sterile, single-use, reusable, or MRI-safe in the provided data, so no claims about sterility or single-use status can be made based on the available information.

  • What regulatory pathway was used for the ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT?

    The device received traditional 510(k) clearance as substantially equivalent to a predicate device under FDA regulation 862.1050 and is classified as a Class II medical device.