Rubella Igg
FDA 510(k) K902793 · Pharmacia Diagnostics, Inc.
510(k) numberK902793
Submission
- Device name
- Rubella Igg
- Applicant
- Pharmacia Diagnostics, Inc.
Columbia, MD, US - Received
- June 26, 1990
- Decision date
- July 31, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K052793 | Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models 14-4425-40, 10-9306-02MST · Traditional | 02/07/2006SE |
| K051218 | Modification to: Unicap Specific IgeDHB · Special | 06/09/2005SE |
| K023433 | Varelisa Cardiolipin Antibodies Screen, Models 15848 and 15896MID · Traditional | 11/13/2002SE |
| K921011 | Pharmacia CMV Igm ElisaLFZ · Traditional | 07/27/1992SE |
| K920702 | Toxoplasma Gondii (Toxo) Igm Enzyme-Linked ImmunoLGD · Traditional | 07/08/1992SE |
| K915348 | Ebv-Vca Igm ElisaLJN · Traditional | 02/14/1992SE |
| K914022 | Seriological Test Kit/Igm Antibody Vari-Zost VirusLFY · Traditional | 01/27/1992SE |
| K912026 | Delfia(R) 17 -Oh-Progesteron KitJLX · Traditional | 06/25/1991SE |
| K902792 | Toxoplasma Gondii IggLGD · Traditional | 07/24/1990SE |
Questions and answers
When was Rubella Igg cleared by the FDA?
Rubella Igg (K902793) received a 510(k) decision of Substantially Equivalent on July 31, 1990, 35 days after the submission was received.
What is the product code of K902793?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.