Cleared Traditional

THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR

K992166 · Zeus Scientific, Inc. · Microbiology

Sep 1999

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K992166 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on September 3, 1999, 70 days after receiving the submission on June 25, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K992166 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 1999
Decision Date	September 03, 1999
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

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