UNI-GOLD STREP A TEST KIT— 510(k) K011709

Substantially Equivalent

Trinity Biotech, Plc

FDA 510(k) clearance K011709 for UNI-GOLD STREP A TEST KIT, Substantially Equivalent on 2001-11-08. Applicant: Trinity Biotech, Plc.

Clearance details

Applicant: Trinity Biotech, Plc
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 2001-06-04
Decision date: 2001-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballinasloe, IE

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