Cleared Traditional

FLUOROSET IMMUNOFLUORESCENT ANTIBODY

K822785 · Immulok, Inc. · Microbiology
Nov 1982
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K822785 is an FDA 510(k) clearance for the FLUOROSET IMMUNOFLUORESCENT ANTIBODY, 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 November 29, 1982, 76 days after receiving the submission on September 14, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K822785 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1982
Decision Date November 29, 1982
Days to Decision 76 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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