Cleared Traditional

ENA PROFILE ELISA TEST SYSTEM

K993839 · Trinity Biotech USA · Immunology
Jan 2000
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K993839 is an FDA 510(k) clearance for the ENA PROFILE ELISA TEST SYSTEM, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on January 12, 2000, 61 days after receiving the submission on November 12, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K993839 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1999
Decision Date January 12, 2000
Days to Decision 61 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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