Cleared Traditional

HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G

K000238 · Mrl Diagnostics · Microbiology

Apr 2000

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K000238 is an FDA 510(k) clearance for the HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Mrl Diagnostics (Cypress, US). The FDA issued a Cleared decision on April 14, 2000, 78 days after receiving the submission on January 27, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K000238 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2000
Decision Date	April 14, 2000
Days to Decision	78 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