Virgo(Tm) Rubella Igg Elisa
FDA 510(k) K873088 · Electro-Nucleonics Laboratories, Inc.
510(k) numberK873088
Submission
- Device name
- Virgo(Tm) Rubella Igg Elisa
- Applicant
- Electro-Nucleonics Laboratories, Inc.
Columbia, MD, US - Received
- August 5, 1987
- Decision date
- September 9, 1987
- 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 |
|---|---|---|
| K873925 | Virgo(Tm) Measles Igg ElisaLJB · Traditional | 02/24/1988SE |
| K873617 | Gemstar II SystemJJE · Traditional | 10/19/1987SE |
| K873416 | Multi-Access Reagent DispenserJQW · Traditional | 10/09/1987SE |
| K873358 | Gemeni Uric Acid U.V.CDO · Traditional | 09/11/1987SE |
| K871905 | Toxoplasma Gondii Igg ElisaLGD · Traditional | 07/30/1987SE |
| K870928 | Cholesterol (Total) Analysis ProductsCHH · Traditional | 04/22/1987SE |
| K863874 | Lipase Hydrolysis/Glycerol Kinase, TriglyceridesCDT · Traditional | 11/13/1986SE |
| K862640 | Amylase LTSCJA · Traditional | 09/09/1986SE |
| K853372 | Gemstar Ipa Theophylline Test KitKLS · Traditional | 09/04/1985SE |
| K853373 | Delta Trol I & IIJJT · Traditional | 08/23/1985SE |
Questions and answers
When was Virgo(Tm) Rubella Igg Elisa cleared by the FDA?
Virgo(Tm) Rubella Igg Elisa (K873088) received a 510(k) decision of Substantially Equivalent on September 9, 1987, 35 days after the submission was received.
What is the product code of K873088?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.