I.M.N. Latex
FDA 510(k) K874678 · Biokit USA, Inc.
510(k) numberK874678
Submission
- Device name
- I.M.N. Latex
- Applicant
- Biokit USA, Inc.
Barcelona, Spain, US - Received
- November 13, 1987
- Decision date
- December 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K913467 | ToxogenLLA · Traditional | 01/11/1993SE |
| K910541 | Biokit RPRGMQ · Traditional | 10/18/1991SE |
| K904310 | Rheumagen RF T-ControlDHR · Traditional | 05/31/1991SE |
| K910539 | Rheumajet RFDHR · Traditional | 04/05/1991SE |
| K910686 | Rheumajet CRPDCN · Traditional | 03/19/1991SE |
| K904311 | Rheumagen Aso T-ControlGTQ · Traditional | 01/25/1991SE |
| K904312 | Rheumagen CRP T-ControlDCK · Traditional | 10/01/1990SE |
| K896433 | Modified RubagenLQN · Traditional | 11/29/1989SE |
| K896272 | Quantex CRP Plus (Latex, Buffer, Standard, ControlDCN · Traditional | 11/08/1989SE |
| K896271 | Quantex RF Plus (Latex, Buffer Standard, Control)DHR · Traditional | 11/08/1989SE |
Questions and answers
When was I.M.N. Latex cleared by the FDA?
I.M.N. Latex (K874678) received a 510(k) decision of Substantially Equivalent on December 14, 1987, 31 days after the submission was received.
What is the product code of K874678?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.