Cleared Traditional

MAGO 4S

K093101 · Diamedix Corp. · Microbiology
Jan 2011
Decision
477d
Days
Class 2
Risk

About This 510(k) Submission

K093101 is an FDA 510(k) clearance for the MAGO 4S, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on January 21, 2011, 477 days after receiving the submission on October 1, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K093101 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2009
Decision Date January 21, 2011
Days to Decision 477 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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