Dryspot Infectious Mononucleosis Kit
FDA 510(k) K982634 · Oxoid , Ltd.
510(k) numberK982634
Submission
- Device name
- Dryspot Infectious Mononucleosis Kit
- Applicant
- Oxoid , Ltd.
Basingstoke, GB - Received
- July 28, 1998
- Decision date
- January 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K961550 | Qualitrol Mono Control Serum SetKTN · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
More from Consolidated Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070262 | Ertapenem Antimicrobial Susceptibility Test DiscJTN · Traditional | 03/14/2007SE |
| K060286 | Tigecycline Antimicrobial Susceptibility Test DiscJTN · Traditional | 03/17/2006SE |
| K042157 | Daptomycin Antimicrobial Susceptibility Test DiscJTN · Traditional | 09/14/2004SE |
| K011710 | Oxoid PBP2 1 Latex Agglutination TestMYI · Traditional | 04/02/2002SE |
| K012588 | Oxoid Pylori Test Kit, Model DR0130MLYR · Traditional | 12/10/2001SE |
| K010537 | Linezolid Antimicrobial Susceptibility Test DiscJTN · Traditional | 04/24/2001SE |
| K010536 | Moxifloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 04/24/2001SE |
| K000930 | Gatifloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 05/22/2000SE |
| K000928 | Quinupristin/Dalfopristin Antimicrobial Susceptibility Test DiscJTN · Traditional | 05/15/2000SE |
| K993401 | Dryspot E.Coli 0157 KitGNA · Traditional | 02/28/2000SE |
Questions and answers
When was Dryspot Infectious Mononucleosis Kit cleared by the FDA?
Dryspot Infectious Mononucleosis Kit (K982634) received a 510(k) decision of Substantially Equivalent on January 28, 1999, 184 days after the submission was received.
What is the product code of K982634?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.