Cleared Traditional

HSV-2 IGG ELISA TEST

K910952 · Gull Laboratories, Inc. · Microbiology

May 1991

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K910952 is an FDA 510(k) clearance for the HSV-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 May 28, 1991, 82 days after receiving the submission on March 7, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K910952 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 1991
Decision Date	May 28, 1991
Days to Decision	82 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