Cytotech Rubella Igg Enzyme Immunoassay
FDA 510(k) K864315 · Cytotech, Inc.
510(k) numberK864315
Submission
- Device name
- Cytotech Rubella Igg Enzyme Immunoassay
- Applicant
- Cytotech, Inc.
San Diego, CA, US - Received
- November 3, 1986
- Decision date
- February 2, 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 |
|---|---|---|
| K882829 | Circulating Immune Complexes ControlsDAK · Traditional | 08/04/1988SE |
| K874379 | Cic-Raji Cell Replacement Enzyme ImmunoassayCZY · Traditional | 11/25/1987SE |
| K873249 | Antinuclear Antibody (Ana) Positive ControlsLKJ · Traditional | 09/22/1987SE |
| K872426 | Cytotech C1-INHIBITOR Enzyme ImmunoassayDBA · Traditional | 07/23/1987SE |
| K871801 | Cytotech Antinuclear Antibody (Ana) Ifa KitDHN · Traditional | 06/09/1987SE |
| K862838 | Cytotech HSV Igg Enzyme ImmunoassayGCO · Traditional | 12/09/1986SE |
| K863363 | Cytotech Toxoplasma Igg Enzyme ImmunoassayLGD · Traditional | 11/13/1986SE |
| K862649 | Cytotech Cic Enzyme ImmunoassayDAK · Traditional | 09/04/1986SE |
| K860493 | Cytotech CMV Igg EiaGQI · Traditional | 05/20/1986SE |
Questions and answers
When was Cytotech Rubella Igg Enzyme Immunoassay cleared by the FDA?
Cytotech Rubella Igg Enzyme Immunoassay (K864315) received a 510(k) decision of Substantially Equivalent on February 2, 1987, 91 days after the submission was received.
What is the product code of K864315?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.