Cleared Special

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

K181436 · SEKISUI Diagnostics, LLC · Microbiology
Jun 2018
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K181436 is an FDA 510(k) clearance for the OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by SEKISUI Diagnostics, LLC (San Diegi, US). The FDA issued a Cleared decision on June 22, 2018, 21 days after receiving the submission on June 1, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K181436 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2018
Decision Date June 22, 2018
Days to Decision 21 days
Submission Type Special
Review Panel Microbiology (MI)
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
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
K042272 · ACON Laboratories, Inc. · Feb 2005
BIORAPID MONONUCLEOSIS
K030215 · Instrumentation Laboratory CO · Feb 2003
COLOR-MONOGEN
K012901 · Instrumentation Laboratory CO · Sep 2001
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