Cleared Traditional

VISIBLE-HERPES TM TEST SYSTEM

K854712 · Isolab, Inc. · Microbiology
May 1986
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K854712 is an FDA 510(k) clearance for the VISIBLE-HERPES TM TEST SYSTEM, a Antisera, Cf, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQO), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on May 20, 1986, 179 days after receiving the submission on November 22, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K854712 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1985
Decision Date May 20, 1986
Days to Decision 179 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

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