Card Three Im Test Item #2035, Card One Im #2036

Q: What is the product code of K853144?

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

FDA 510(k) K853144 · Preco, Inc.

Substantially Equivalent

510(k) numberK853144

Submission

Device name: Card Three Im Test Item #2035, Card One Im #2036
Applicant: Preco, Inc.
Oakland, NJ, US
Received: July 29, 1985
Decision date: October 16, 1985
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)	Device	Applicant	Decision
K181436	OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II…KTN · Special	SEKISUI Diagnostics, LLC	06/22/2018SE
K042272	Acon Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma)KTN · Traditional	ACON Laboratories, Inc.	02/28/2005SE
K030215	Biorapid MononucleosisKTN · Traditional	Instrumentation Laboratory CO	02/24/2003SE
K012901	Color-MonogenKTN · Traditional	Instrumentation Laboratory CO	09/27/2001SE
K982634	Dryspot Infectious Mononucleosis KitKTN · Traditional	Oxoid , Ltd.	01/28/1999SE
K981946	Clearview ImKTN · Traditional	Unipath , Ltd.	12/10/1998SE
K972457	Monocol/Lex-Im TestKTN · Traditional	Immunostics Inc.,	12/01/1997SE
K972231	Osom Mono Test 143KTN · Traditional	Wyntek Diagnostics, Inc.	08/26/1997SE
K963425	Genzyme Diagnostics Contrast MonoKTN · Traditional	Genzyme Diagnostics	02/25/1997SE
K961024	Biosign 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)	Device	Decision
K852751	Tolvidine Red Unheated Serum Syphillis Card TestGMQ · Traditional	08/20/1985SE
K853054	RF Card TestDHR · Traditional	08/01/1985SE
K850604	Preco Pregnancy Rapid Card Test, Hem #2028JHJ · Traditional	04/08/1985SE

Questions and answers

When was Card Three Im Test Item #2035, Card One Im #2036 cleared by the FDA?

Card Three Im Test Item #2035, Card One Im #2036 (K853144) received a 510(k) decision of Substantially Equivalent on October 16, 1985, 79 days after the submission was received.

What is the product code of K853144?

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