Biosign Mono-Plus Wb,Biosign Mono Wb,Mono-Plus Wb,Accusign Mono WB
FDA 510(k) K961024 · Princeton BioMeditech Corp.
510(k) numberK961024
Submission
- Device name
- Biosign Mono-Plus Wb,Biosign Mono Wb,Mono-Plus Wb,Accusign Mono WB
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- March 14, 1996
- Decision date
- February 4, 1997
- 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 |
| 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 |
| K961550 | Qualitrol Mono Control Serum SetKTN · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
More from Consolidated Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251538 | Status COVID-19/Flu A&BSCA · Dual Track | 11/14/2025SE |
| K182157 | BioSign Flu A+BPSZ · Special | 09/18/2018SE |
| K130650 | Status DS OxyDJG · Traditional | 02/26/2014SE |
| K133474 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 12/10/2013SE |
| K132465 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 09/09/2013SE |
| K083746 | Biosign Flu A+BPSZ · Traditional | 11/10/2010SE |
| K100817 | Biosign Ifobtest, Biosign Fecal Occult Blood TestKHE · Traditional | 07/01/2010SE |
| K100341 | Spermcheck FertilityPOV · Traditional | 05/04/2010SE |
| K082661 | Biostrep a, Biosign Strep a, Statusfirst Strep aGTY · Special | 10/06/2008SE |
| K073039 | Spermcheck VasectomyPOV · Traditional | 01/24/2008SE |
Questions and answers
When was Biosign Mono-Plus Wb,Biosign Mono Wb,Mono-Plus Wb,Accusign Mono WB cleared by the FDA?
Biosign Mono-Plus Wb,Biosign Mono Wb,Mono-Plus Wb,Accusign Mono WB (K961024) received a 510(k) decision of Substantially Equivalent on February 4, 1997, 327 days after the submission was received.
What is the product code of K961024?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.