CAPTIA SYPHILIS-G ELISA TEST SYSTEM— 510(k) K001525

Name: FDA 510(k) clearance K001525
Creator: U.S. Food and Drug Administration
Published: 2000-11-29

Substantially Equivalent

Trinity Biotech, Plc

FDA 510(k) clearance K001525 for CAPTIA SYPHILIS-G ELISA TEST SYSTEM, Substantially Equivalent on 2000-11-29. 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: 2000-05-16
Decision date: 2000-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, US

Download summary PDF View on FDA.gov ↗

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