ENA PROFILE ELISA TEST SYSTEM— 510(k) K993839

Name: FDA 510(k) clearance K993839
Creator: U.S. Food and Drug Administration
Published: 2000-01-12

Substantially Equivalent

Trinity Biotech USA

FDA 510(k) clearance K993839 for ENA PROFILE ELISA TEST SYSTEM, Substantially Equivalent on 2000-01-12. Applicant: Trinity Biotech USA. Device class: 2.

Clearance details

Applicant: Trinity Biotech USA
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1999-11-12
Decision date: 2000-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, US

Download summary PDF View on FDA.gov ↗

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