Cleared Traditional

HSV-1 IGM ELISA TEST -- MODIFICATION

K922758 · Gull Laboratories, Inc. · Microbiology

Oct 1992

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K922758 is an FDA 510(k) clearance for the HSV-1 IGM ELISA TEST -- MODIFICATION, 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 October 5, 1992, 119 days after receiving the submission on June 8, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K922758 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 1992
Decision Date	October 05, 1992
Days to Decision	119 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