Cleared Traditional

POCKIT HSV 2 RAPID TEST

K983886 · Diagnology , Ltd. · Microbiology

Aug 1999

Decision

290d

Days

Class 2

Risk

About This 510(k) Submission

K983886 is an FDA 510(k) clearance for the POCKIT HSV 2 RAPID TEST, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Diagnology , Ltd. (West Cadwell, US). The FDA issued a Cleared decision on August 19, 1999, 290 days after receiving the submission on November 2, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K983886 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 1998
Decision Date	August 19, 1999
Days to Decision	290 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