Cleared Traditional

COLOR-MONOGEN

K012901 · Instrumentation Laboratory CO · Immunology
Sep 2001
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K012901 is an FDA 510(k) clearance for the COLOR-MONOGEN, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 27, 2001, 29 days after receiving the submission on August 29, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K012901 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2001
Decision Date September 27, 2001
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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

Similar Devices — KTN System, Test, Infectious Mononucleosis

All 58
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
K181436 · SEKISUI Diagnostics, LLC · Jun 2018
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
K042272 · ACON Laboratories, Inc. · Feb 2005
BIORAPID MONONUCLEOSIS
K030215 · Instrumentation Laboratory CO · Feb 2003
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
K982634 · Oxoid , Ltd. · Jan 1999
CLEARVIEW IM
K981946 · Unipath , Ltd. · Dec 1998
MONOCOL/LEX-IM TEST
K972457 · Immunostics Inc., · Dec 1997