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MAGO 4S

by Diamedix Corp.

510(k) K093101

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093101 Date21 Jan 2011ClearedStatusActive

Official records

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  • Withdrawn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
LFX
Device class
Class II
Regulation
21 CFR Part 866.3510
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 MAGO 4S is an automated immunoassay analyzer used for ELISA and IFA testing in laboratory settings. It is designed to process ELISA and IFA samples simultaneously, providing laboratories with multi-parameter testing capabilities and increased efficiency.

This Class 2 Microbiology device (product code LFX) is manufactured by Diamedix Corp. and is supplied as a reusable analyzer. It received FDA 510(k) clearance through the Traditional pathway on January 21, 2011, with the K number K093101. The device is intended for use in laboratory environments for microbiology testing purposes.

Similar devices

Other devices filed under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella).

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