Cleared Traditional

HERPES GROUP IGG ELISA TEST SYSTEM

K963645 · Armkel, LLC · Microbiology

Feb 1997

Decision

145d

Days

Class 2

Risk

About This 510(k) Submission

K963645 is an FDA 510(k) clearance for the HERPES GROUP IGG ELISA TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Armkel, LLC (Frederick, US). The FDA issued a Cleared decision on February 4, 1997, 145 days after receiving the submission on September 12, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K963645 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 1996
Decision Date	February 04, 1997
Days to Decision	145 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