Cleared Traditional

HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING

K904095 · California Integrated Diagnostics, Inc. · Microbiology
Feb 1991
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K904095 is an FDA 510(k) clearance for the HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING, a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQL), submitted by California Integrated Diagnostics, Inc. (Benica, US). The FDA issued a Cleared decision on February 1, 1991, 148 days after receiving the submission on September 6, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K904095 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1990
Decision Date February 01, 1991
Days to Decision 148 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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