Rubella Igm Eia Test Kit
FDA 510(k) K862431 · Labsystems, Inc.
510(k) numberK862431
Submission
- Device name
- Rubella Igm Eia Test Kit
- Applicant
- Labsystems, Inc.
Morton Grove, IL, US - Received
- June 26, 1986
- Decision date
- August 8, 1986
- 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 |
|---|---|---|
| K923365 | Tilt/Reduced Shear Semi-Recline Seating SystemITI · Traditional | 03/24/1993SE |
| K896474 | Resubmitted Fecatwin Sensitive - Feca-EiaKHE · Traditional | 01/25/1990SE |
| K890154 | Modified Labysystems' Toxoplasma Gondii Igg EiaLGD · Traditional | 02/07/1989SE |
| K890091 | Modified Labsystems' Rubella Igg Eia Test KitLFX · Traditional | 02/03/1989SE |
| K881243 | Rubella Igg - Eia Test Kit Number 61 07 201LFX · Traditional | 04/04/1988SE |
| K873780 | Modification Rubella Igm Eia Test KitLFX · Traditional | 10/15/1987SE |
| K873583 | Auto-EiaJJQ · Traditional | 09/22/1987SE |
| K872252 | Modified Toxoplasma Gondii Igg Eia Test KitLGD · Traditional | 07/01/1987SE |
| K862705 | Cytomegalovirus Igg Eia Test KitGQI · Traditional | 10/01/1986SE |
| K862216 | Toxoplasma Gondii Igg Eia Test Kit (Amendment)LGD · Traditional | 06/30/1986SE |
Questions and answers
When was Rubella Igm Eia Test Kit cleared by the FDA?
Rubella Igm Eia Test Kit (K862431) received a 510(k) decision of Substantially Equivalent on August 8, 1986, 43 days after the submission was received.
What is the product code of K862431?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.