Cleared Traditional

UNI-GOLD CRYPTOSPORIDIUM

K121565 · Trinity Biotech · Microbiology
Feb 2013
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K121565 is an FDA 510(k) clearance for the UNI-GOLD CRYPTOSPORIDIUM, a Cryptosporidium Spp. (Class II — Special Controls, product code MHJ), submitted by Trinity Biotech (Carlsbad, US). The FDA issued a Cleared decision on February 8, 2013, 255 days after receiving the submission on May 29, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K121565 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2012
Decision Date February 08, 2013
Days to Decision 255 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MHJ — Cryptosporidium Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220

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