Cleared Traditional

IMMUNO-IM

K853105 · Immunostics Co., Inc. · Immunology
Sep 1985
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K853105 is an FDA 510(k) clearance for the IMMUNO-IM, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Immunostics Co., Inc. (Metuchen, US). The FDA issued a Cleared decision on September 3, 1985, 42 days after receiving the submission on July 23, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K853105 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1985
Decision Date September 03, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code KTN — System, Test, Infectious Mononucleosis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5640

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