Cleared Traditional

HSV 1+2 IGG ELISA TEST

K983541 · Gull Laboratories, Inc. · Microbiology

Feb 1999

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K983541 is an FDA 510(k) clearance for the HSV 1+2 IGG ELISA TEST, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 26, 1999, 140 days after receiving the submission on October 9, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K983541 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 1998
Decision Date	February 26, 1999
Days to Decision	140 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