Cleared Traditional

HERPES GROUP IGG

K033059 · Trinity Biotech, Inc. · Microbiology

Nov 2003

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K033059 is an FDA 510(k) clearance for the HERPES GROUP IGG, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Trinity Biotech, Inc. (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 866.3305.

Submission Details

510(k) Number	K033059 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	LGC — Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305