Cleared Traditional

INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1

K905608 · Stellar Bio Systems, Inc. · Microbiology
Nov 1991
Decision
328d
Days
Class 2
Risk

About This 510(k) Submission

K905608 is an FDA 510(k) clearance for the INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1, a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQL), submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on November 7, 1991, 328 days after receiving the submission on December 14, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K905608 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1990
Decision Date November 07, 1991
Days to Decision 328 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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