Im-Check

FDA 510(k) K834345 · Diagnostic Technology, Inc.

Substantially Equivalent

510(k) numberK834345

Submission

Device name
Im-Check
Applicant
Diagnostic Technology, Inc.
Mchenry, IL, US
Received
December 12, 1983
Decision date
February 10, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KTN – System, Test, Infectious Mononucleosis
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5640
Specialty
Immunology

Other 510(k)s with product code KTN

510(k)DeviceApplicantDecision
K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II…KTN · Special SEKISUI Diagnostics, LLC06/22/2018SE
K042272Acon Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma)KTN · Traditional ACON Laboratories, Inc.02/28/2005SE
K030215Biorapid MononucleosisKTN · Traditional Instrumentation Laboratory CO02/24/2003SE
K012901Color-MonogenKTN · Traditional Instrumentation Laboratory CO09/27/2001SE
K982634Dryspot Infectious Mononucleosis KitKTN · Traditional Oxoid , Ltd.01/28/1999SE
K981946Clearview ImKTN · Traditional Unipath , Ltd.12/10/1998SE
K972457Monocol/Lex-Im TestKTN · Traditional Immunostics Inc.,12/01/1997SE
K972231Osom Mono Test 143KTN · Traditional Wyntek Diagnostics, Inc.08/26/1997SE
K963425Genzyme Diagnostics Contrast MonoKTN · Traditional Genzyme Diagnostics02/25/1997SE
K961024Biosign Mono-Plus Wb,Biosign Mono Wb,Mono-Plus Wb,Accusign Mono WBKTN · Traditional Princeton BioMeditech Corp.02/04/1997SE

More from Princeton BioMeditech Corp.

510(k)DeviceDecision
K896378Lyme-Check(Tm) Test KitLSR · Traditional 11/05/1991SE
K903612Ebv/Ea-Check TM Test KitLSE · Traditional 10/16/1990SE
K891542Ebna-Check(Tm) Test KitLLM · Traditional 06/20/1989SE
K890819Hsv-Check(Tm) Test KitHIS · Traditional 06/20/1989SE
K890639Resubmitted Ebv/Igm-Check Test KitLJN · Traditional 06/20/1989SE
K871373Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional 06/25/1987SE
K864128Chlamydia-Check(Tm) Direct & Culture Confir. KitLJP · Traditional 04/29/1987SE
K863408Ebv/Vca-Check(Tm) Antigen SlidesGNP · Traditional 11/28/1986SE
K860586PHA-2 Conversion Program for Platelet AnalysisGKL · Traditional 05/07/1986SE
K860166Picoscale Blood Cell Counter, Model PS-5GKL · Traditional 04/04/1986SE

Questions and answers

When was Im-Check cleared by the FDA?

Im-Check (K834345) received a 510(k) decision of Substantially Equivalent on February 10, 1984, 60 days after the submission was received.

What is the product code of K834345?

The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.