Cleared Traditional

IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS

K910499 · Vitek Systems, Inc. · Microbiology

May 1991

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K910499 is an FDA 510(k) clearance for the IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Vitek Systems, Inc. (Rockland, US). The FDA issued a Cleared decision on May 1, 1991, 85 days after receiving the submission on February 5, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K910499 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 1991
Decision Date	May 01, 1991
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

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