Cleared Traditional

VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

K951799 · Light Diagnostics · Microbiology
Mar 1996
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K951799 is an FDA 510(k) clearance for the VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY, a Antiserum, Cf, Varicella-zoster (Class II — Special Controls, product code GQX), submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on March 20, 1996, 336 days after receiving the submission on April 19, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K951799 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1995
Decision Date March 20, 1996
Days to Decision 336 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GQX — Antiserum, Cf, Varicella-zoster
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3900

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