Biosign(Tm) Mono-Infect Mono Hetero Antibody Test
FDA 510(k) K925183 · Princeton Biomedix
510(k) numberK925183
Submission
- Device name
- Biosign(Tm) Mono-Infect Mono Hetero Antibody Test
- Applicant
- Princeton Biomedix
Princeton, NJ, US - Received
- October 14, 1992
- Decision date
- February 23, 1993
- 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 |
| 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 |
|---|---|---|
| K942052 | Lifesign Mi MyoglobinDDR · Traditional | 02/07/1995SE |
| K925355 | Biosign(Tm_ Rubella - Rubella Antibody TestLFX · Traditional | 07/12/1994SE |
| K930185 | Ovusign Lh/Conception Plus/Ovudate LH One-StepCEP · Traditional | 03/04/1993SE |
| K926308 | Lifesign HCG - One Step Home Pregnancy TestLCX · Traditional | 01/26/1993SE |
| K901011 | Biosign Hcg-One Step Pregnancy TestJHI · Traditional | 05/04/1990SE |
| K894750 | Biostix I. HCG - One Step Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K894705 | Biospot Hcg-Rapid Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K892654 | Biostix (Tm)Hcg--Simple Pregnancy TestDHA · Traditional | 06/19/1989SE |
| K761315 | Alkaline Phosphatase (Alp)/PnppCJE · Traditional | 02/24/1977SE |
| K760346 | Assay for Gamma GlutamyltransferaseJPZ · Traditional | 10/27/1976SE |
Questions and answers
When was Biosign(Tm) Mono-Infect Mono Hetero Antibody Test cleared by the FDA?
Biosign(Tm) Mono-Infect Mono Hetero Antibody Test (K925183) received a 510(k) decision of Substantially Equivalent on February 23, 1993, 132 days after the submission was received.
What is the product code of K925183?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.