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Acid Phosphatase Diag. Kit

by Sclavo, Inc. 510(k)

Active United States

510(k) K781489

Overview

The Acid Phosphatase Diagnostic Kit is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum. It is classified as a Clinical Chemistry device and is used for diagnostic purposes.

This kit is supplied by Sclavo, Inc. and is a Class II device with FDA 510(k) clearance. It is regulated under product code CJN and received FDA clearance on October 3, 1978. The device is intended for laboratory use and measures acid phosphatase activity in clinical specimens.

AI-generated from registry data, 27 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 NumberK781489 Date3 Oct 1978ClearedStatusActive

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
CJN
Device Class
Class II
Regulation
21 CFR Part 862.1020
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Acid Phosphatase Diagnostic Kit used for?

    The Acid Phosphatase Diagnostic Kit is used to measure the activity of the acid phosphatase enzyme in plasma and serum specimens for diagnostic purposes in clinical laboratory settings.

  • How is the Acid Phosphatase Diagnostic Kit supplied?

    The kit is supplied by Sclavo, Inc. as a Class II device intended for laboratory use. It contains all necessary components for measuring acid phosphatase activity in clinical specimens.

  • Is the Acid Phosphatase Diagnostic Kit single-use or reusable?

    The device is intended for laboratory use and measures acid phosphatase activity in clinical specimens. The description does not specify whether individual components are single-use or reusable.

  • What is the regulatory status of the Acid Phosphatase Diagnostic Kit?

    The Acid Phosphatase Diagnostic Kit is a Class II device with FDA 510(k) clearance (K781489) received on October 3, 1978. It is regulated under product code CJN and is classified as a Clinical Chemistry device.