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Amer. Histo-id Sys Primary Iga 2720-21

by Bartels Immunodiagnostic Supplies, Inc.

510(k) K842330

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 NumberK842330 Date2 Aug 1984ClearedStatusActive

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  • Withdrawn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
CZP
Device Class
Class II
Regulation
21 CFR Part 866.5510
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Amer. Histo-id Sys Primary Iga 2720-21 is an immunology device used for diagnostic testing. It is classified as an Iga, Antigen, Antiserum, Control and is manufactured by Bartels Immunodiagnostic Supplies, Inc.

This device is supplied in a single-use format and is regulated under FDA 510K clearance with product code CZP. It is intended for use in immunology testing applications and is stored according to manufacturer specifications.

Other devices from Bartels Immunodiagnostic Supplies, Inc.

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Questions

AI-generated answers, 27 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 Amer Histo-id Sys Primary Iga 2720-21 used for?

    The Amer Histo-id Sys Primary Iga 2720-21 is used for diagnostic testing in immunology applications, specifically as an Iga, Antigen, Antiserum, Control.

  • Is the Amer Histo-id Sys Primary Iga 2720-21 reusable?

    No, the Amer Histo-id Sys Primary Iga 2720-21 is supplied in a single-use format.

  • How is the Amer Histo-id Sys Primary Iga 2720-21 stored?

    The Amer Histo-id Sys Primary Iga 2720-21 is stored according to manufacturer specifications.

  • What regulatory clearance does the Amer Histo-id Sys Primary Iga 2720-21 have?

    The Amer Histo-id Sys Primary Iga 2720-21 has FDA 510K clearance with product code CZP.