Cleared Traditional

CHLAMYDIA IGG ELISA TEST SYSTEM

K033079 · Trinity Biotech USA · Microbiology
Nov 2003
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K033079 is an FDA 510(k) clearance for the CHLAMYDIA IGG ELISA TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I — General Controls, product code LJC), submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on November 26, 2003, 58 days after receiving the submission on September 29, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K033079 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2003
Decision Date November 26, 2003
Days to Decision 58 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJC — Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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