UNI-GOLD CRYPTOSPORIDIUM— 510(k) K121565

Substantially Equivalent

Trinity Biotech

FDA 510(k) clearance K121565 for UNI-GOLD CRYPTOSPORIDIUM, Substantially Equivalent on 2013-02-08. Applicant: Trinity Biotech. Device class: 2.

Clearance details

Applicant: Trinity Biotech
Product code: Code MHJ
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 2012-05-29
Decision date: 2013-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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