UNIGOLD GIARDIA— 510(k) K120001

Substantially Equivalent

Trinity Biotech

FDA 510(k) clearance K120001 for UNIGOLD GIARDIA, Substantially Equivalent on 2013-03-01. Applicant: Trinity Biotech. Device class: 2.

Clearance details

Applicant: Trinity Biotech
Product code: Code MHI
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 2012-01-03
Decision date: 2013-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MHI

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K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 24500202003-11-18
K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY2003-11-10
K033274 — GIARDIA II2003-11-04

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K121565 — UNI-GOLD CRYPTOSPORIDIUM2013-02-08
K083896 — DESTINY MAX COAGULATION ANALYZER2009-07-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.