Cleared Traditional

DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM

K002262 · Diamedix Corp. · Microbiology

Nov 2000

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K002262 is an FDA 510(k) clearance for the DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on November 28, 2000, 126 days after receiving the submission on July 25, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K002262 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2000
Decision Date	November 28, 2000
Days to Decision	126 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