Cleared Traditional

HERPES SIMPLEX VIRUS TYPING REAGENTS

K830971 · Immulok, Inc. · Microbiology
Jun 1983
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K830971 is an FDA 510(k) clearance for the HERPES SIMPLEX VIRUS TYPING REAGENTS, a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQL), submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983, 94 days after receiving the submission on March 28, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K830971 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1983
Decision Date June 30, 1983
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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