Mono-Cube(Tm)

FDA 510(k) K890991 · Difco Laboratories, Inc.

Substantially Equivalent

510(k) numberK890991

Submission

Device name
Mono-Cube(Tm)
Applicant
Difco Laboratories, Inc.
Detroit, MI, US
Received
February 27, 1989
Decision date
March 16, 1989
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

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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
K971211Dispens-O-Disc SparfloxacinJTN · Traditional 04/14/1997SE
K971120Dispens-O-Disc (TM) LevofloxacinJTN · Traditional 04/14/1997SE
K963508Dispens-O-Disc MeropenemJTN · Traditional 09/26/1996SE
K961148Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional 04/26/1996SE
K954783Dryslide CartarrhalisJTO · Traditional 02/06/1996SE
K954784Dryside NeisseriaLTS · Traditional 01/30/1996SE
K953129Esp Culture System - MycoMDB · Traditional 12/26/1995SE
K950706Dryslide CoagulaseJTL · Traditional 05/16/1995SE
K944275Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional 12/19/1994SE
K941016Dispens-O-Disc(Tm) NitrocefinJTO · Traditional 06/30/1994SE

Questions and answers

When was Mono-Cube(Tm) cleared by the FDA?

Mono-Cube(Tm) (K890991) received a 510(k) decision of Substantially Equivalent on March 16, 1989, 17 days after the submission was received.

What is the product code of K890991?

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