Cleared Traditional

MONOCOL/LEX-IM TEST

K972457 · Immunostics Inc., · Immunology
Dec 1997
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K972457 is an FDA 510(k) clearance for the MONOCOL/LEX-IM TEST, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on December 1, 1997, 153 days after receiving the submission on July 1, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K972457 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1997
Decision Date December 01, 1997
Days to Decision 153 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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