Cleared Traditional

CAPTIA SYPHILIS-G ELISA TEST SYSTEM

K001525 · Trinity Biotech, Plc · Microbiology
Nov 2000
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K001525 is an FDA 510(k) clearance for the CAPTIA SYPHILIS-G ELISA TEST SYSTEM, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Trinity Biotech, Plc (Jamestown, US). The FDA issued a Cleared decision on November 29, 2000, 197 days after receiving the submission on May 16, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K001525 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2000
Decision Date November 29, 2000
Days to Decision 197 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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