Healthtest Infectious Mononucleosis Assay

FDA 510(k) K920221 · Akers Research Corp.

Substantially Equivalent

510(k) numberK920221

Submission

Device name
Healthtest Infectious Mononucleosis Assay
Applicant
Akers Research Corp.
Thorofare, NJ, US
Received
January 16, 1992
Decision date
March 13, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

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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
K920222Healthtest Assay for Antibody to CytomegalovirusLJO · Traditional 07/27/1992SE
K920220Healthtest Rheumatoid Factor AssayDHR · Traditional 03/13/1992SE

Questions and answers

When was Healthtest Infectious Mononucleosis Assay cleared by the FDA?

Healthtest Infectious Mononucleosis Assay (K920221) received a 510(k) decision of Substantially Equivalent on March 13, 1992, 57 days after the submission was received.

What is the product code of K920221?

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