Cleared Special

CAPTIAM SYPHILIS-G ASSAY

K014233 · Trinity Biotech, Plc · Microbiology
Jan 2002
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K014233 is an FDA 510(k) clearance for the CAPTIAM SYPHILIS-G ASSAY, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Trinity Biotech, Plc (Co. Wicklow, IE). The FDA issued a Cleared decision on January 24, 2002, 29 days after receiving the submission on December 26, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K014233 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2001
Decision Date January 24, 2002
Days to Decision 29 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement

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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