CAPTIAM SYPHILIS-G ASSAY— 510(k) K014233

Substantially Equivalent

Trinity Biotech, Plc

FDA 510(k) clearance K014233 for CAPTIAM SYPHILIS-G ASSAY, Substantially Equivalent on 2002-01-24. Applicant: Trinity Biotech, Plc. Device class: 2.

Clearance details

Applicant: Trinity Biotech, Plc
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2001-12-26
Decision date: 2002-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Co. Wicklow, IE

Download summary PDF View on FDA.gov ↗

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