Cleared Traditional

UNIGOLD GIARDIA

K120001 · Trinity Biotech · Microbiology
Mar 2013
Decision
423d
Days
Class 2
Risk

About This 510(k) Submission

K120001 is an FDA 510(k) clearance for the UNIGOLD GIARDIA, a Giardia Spp. (Class II — Special Controls, product code MHI), submitted by Trinity Biotech (Carlsbad, US). The FDA issued a Cleared decision on March 1, 2013, 423 days after receiving the submission on January 3, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K120001 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2012
Decision Date March 01, 2013
Days to Decision 423 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MHI — Giardia Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220

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