Cleared Traditional

PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST

K984346 · Meridian Diagnostics, Inc. · Microbiology

Jun 1999

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K984346 is an FDA 510(k) clearance for the PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 25, 1999, 203 days after receiving the submission on December 4, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K984346 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 1998
Decision Date	June 25, 1999
Days to Decision	203 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