Cleared Traditional

HSV-2 ELISA IGG, MODEL EL0920G

K993724 · Mrl Diagnostics · Microbiology

Feb 2000

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K993724 is an FDA 510(k) clearance for the HSV-2 ELISA IGG, MODEL EL0920G, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II — Special Controls, product code MYF), submitted by Mrl Diagnostics (Cypress, US). The FDA issued a Cleared decision on February 1, 2000, 90 days after receiving the submission on November 3, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K993724 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 1999
Decision Date	February 01, 2000
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305