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MAGO 4S

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093101

by Diamedix Corp.

Identifiers

510(k) Number
K093101 FDA 510(k)
FDA Product Code
LFX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3510 FDA 510(k)
Regulation Number
866.3510 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

Frequently asked questions

What is the MAGO 4S used for in laboratory settings?

The MAGO 4S is an automated immunoassay analyzer designed for processing ELISA and IFA samples simultaneously, providing laboratories with multi-parameter testing capabilities and increased efficiency for microbiology testing purposes.

Is the MAGO 4S a single-use or reusable device?

The MAGO 4S is supplied as a reusable analyzer, meaning it can be used multiple times in laboratory settings for various testing procedures after proper cleaning and maintenance according to manufacturer guidelines.

What regulatory approvals does the MAGO 4S have?

The MAGO 4S received FDA 510(k) clearance through the Traditional pathway on January 21, 2011, with K number K093101. It is classified as a Class 2 Microbiology device with product code LFX, manufactured by Diamedix Corp.

How is the MAGO 4S supplied to laboratories?

The MAGO 4S is supplied as a reusable analyzer unit to laboratories, though the specific packaging and accessories included with the device would depend on the manufacturer's standard supply configuration and any additional options selected by the purchasing laboratory.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K093101 - MAGO 4S | FDA 510 (k) | Diamedix Corp., New Diamedix Mago 4S Elisa Automated Analyzer for Sale at International ..., DIAMEDIX Mago Automated Immunoassay 4S, Diamedix™ Polypropylene Test Tubes for MAGO™ Plus and MAGO™ 4S ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diamedix Corp.

Sources (1)

  • FDA 510(k) K093101 24 fields · synced Sep 24, 2026