Eia Rubella
FDA 510(k) K812787 · Gilford
510(k) numberK812787
Submission
- Device name
- Eia Rubella
- Applicant
- Gilford
Mchenry, IL, US - Received
- October 5, 1981
- Decision date
- November 27, 1981
- 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 |
|---|---|---|
| K853469 | Gilford Immunoglobulin M ReagentDFT · Traditional | 09/16/1985SE |
| K853468 | Gilford C4 Complement ReagentDBI · Traditional | 09/16/1985SE |
| K853467 | Gilford Immunoglobulin a ReagentCZP · Traditional | 09/16/1985SE |
| K853466 | Gilford C3 Complement ReagentCZW · Traditional | 09/16/1985SE |
| K853465 | Gilford Immunoglobulin G ReagentDEW · Traditional | 09/16/1985SE |
| K851202 | Gilford Tri-Level Assayed Immunology ControlDAK · Traditional | 04/29/1985SE |
| K842500 | Data Mgmt. SystemJJE · Traditional | 08/16/1984SE |
| K840120 | AdvantageJJE · Traditional | 03/23/1984SE |
| K833067 | Impact 400 #1447X2JJE · Traditional | 12/08/1983SE |
Questions and answers
When was Eia Rubella cleared by the FDA?
Eia Rubella (K812787) received a 510(k) decision of Substantially Equivalent on November 27, 1981, 53 days after the submission was received.
What is the product code of K812787?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.