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Prospect Giardia

by Alexon, Inc.

510(k) K942098

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 NumberK942098 Date9 Sep 1994ClearedStatusActive

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  • Withdrawn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
MHI
Device Class
Class II
Regulation
21 CFR Part 866.3220
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Prospect Giardia is a microbiology device used for the detection of Giardia specific antigen in human fecal specimens. It is a qualitative enzyme immunoassay for the rapid detection of Giardia. The device is classified as a microbiology device, specifically under the regulation number 866.3220. It is used in the field of microbiology for the detection of Giardia spp.

The Prospect Giardia is supplied with FDA 510K authorization, with the k number K942098. It is a device classified under the product code MHI, with a device class of 2. The device is intended for use in microbiology laboratories for the detection of Giardia. The storage and handling instructions are not specified, but the device is regulated under the FDA guidelines.

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Questions

AI-generated answers, 1 Oct 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 Prospect Giardia device used for?

    The Prospect Giardia is used for the detection of Giardia specific antigen in human fecal specimens, specifically in microbiology laboratories.

  • How is the Prospect Giardia device supplied?

    The device is supplied with FDA 510K authorization, with the k number K942098, and is classified under the product code MHI.

  • What type of assay does the Prospect Giardia use?

    The Prospect Giardia uses a qualitative enzyme immunoassay for the rapid detection of Giardia.

  • What is the regulatory classification of the Prospect Giardia?

    The device is classified as a microbiology device, specifically under the regulation number 866.3220, and has a device class of 2.