Cleared Traditional

PREMIER HSV PLUS

K953839 · Meridian Diagnostics, Inc. · Microbiology

May 1996

Decision

281d

Days

Class 2

Risk

About This 510(k) Submission

K953839 is an FDA 510(k) clearance for the PREMIER HSV PLUS, 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 May 23, 1996, 281 days after receiving the submission on August 16, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K953839 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 1995
Decision Date	May 23, 1996
Days to Decision	281 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