Biosign(Tm_ Rubella - Rubella Antibody Test
FDA 510(k) K925355 · Princeton Biomedix
510(k) numberK925355
Submission
- Device name
- Biosign(Tm_ Rubella - Rubella Antibody Test
- Applicant
- Princeton Biomedix
Princeton, NJ, US - Received
- October 22, 1992
- Decision date
- July 12, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LFX – Enzyme Linked Immunoabsorbent Assay, Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code LFX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250588 | Access Rubella IgGLFX · Traditional | Beckman Coulter, Inc. | 11/17/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | Abbott Laboratories | 06/20/2025SE |
| K122397 | Liaison Rubella Igm, Liaison Control Rubella IgmLFX · Traditional | DiaSorin, Inc. | 09/06/2012SE |
| K093101 | Mago 4SLFX · Traditional | Diamedix Corp. | 01/21/2011SE |
| K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemLFX · Traditional | Bio-Rad Laboratories | 12/03/2010SE |
| K092322 | Elecsys Rubella Igm ImmunoassayLFX · Traditional | Roche Diagnostics | 03/12/2010SE |
| K080766 | Vidas Rub IggLFX · Traditional | bioMerieux, Inc. | 12/23/2008SE |
| K072617 | Elecsys Rubella Igg ImmunoassayLFX · Traditional | Roche Diagnostics Corp. | 12/05/2008SE |
| K073390 | Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-ControlsLFX · Traditional | DiaSorin, Inc. | 11/21/2008SE |
| K063186 | Athena Multi-Lyte Rubella Igg Test SystemLFX · Traditional | Zeus Scientific, Inc. | 03/21/2007SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942052 | Lifesign Mi MyoglobinDDR · Traditional | 02/07/1995SE |
| K930185 | Ovusign Lh/Conception Plus/Ovudate LH One-StepCEP · Traditional | 03/04/1993SE |
| K925183 | Biosign(Tm) Mono-Infect Mono Hetero Antibody TestKTN · Traditional | 02/23/1993SE |
| 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_ Rubella - Rubella Antibody Test cleared by the FDA?
Biosign(Tm_ Rubella - Rubella Antibody Test (K925355) received a 510(k) decision of Substantially Equivalent on July 12, 1994, 628 days after the submission was received.
What is the product code of K925355?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.