Cleared Traditional

LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY

K991880 · Light Diagnostics · Microbiology
Nov 1999
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K991880 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY, a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQN), submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on November 9, 1999, 160 days after receiving the submission on June 2, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K991880 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1999
Decision Date November 09, 1999
Days to Decision 160 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GQN — Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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