Cleared Traditional

HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT

K803132 · Microbiological Research Corp. · Microbiology
Jan 1981
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K803132 is an FDA 510(k) clearance for the HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT, a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQL), submitted by Microbiological Research Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981, 47 days after receiving the submission on December 12, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K803132 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1980
Decision Date January 28, 1981
Days to Decision 47 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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