Mono-Tec
FDA 510(k) K841863 · Medilab Corp.
510(k) numberK841863
Submission
- Device name
- Mono-Tec
- Applicant
- Medilab Corp.
Mchenry, IL, US - Received
- May 4, 1984
- Decision date
- June 13, 1984
- 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 |
|---|---|---|
| K841862 | Immu-TecDCK · Traditional | 06/13/1984SE |
| K840291 | MCS Albumin ReagentCIX · Traditional | 03/30/1984SE |
| K840290 | MCS Total Protein ReagentCEK · Traditional | 03/30/1984SE |
| K840289 | Lyse-TecGGK · Traditional | 03/05/1984SE |
| K832918 | Pregna-TecJHJ · Traditional | 11/03/1983SE |
| K832527 | Pregna-TecJHJ · Traditional | 09/12/1983SE |
Questions and answers
When was Mono-Tec cleared by the FDA?
Mono-Tec (K841863) received a 510(k) decision of Substantially Equivalent on June 13, 1984, 40 days after the submission was received.
What is the product code of K841863?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.