Modification of Serocard Rubella Igg Test
FDA 510(k) K902571 · Disease Detection International, Inc.
510(k) numberK902571
Submission
- Device name
- Modification of Serocard Rubella Igg Test
- Applicant
- Disease Detection International, Inc.
Irvine, CA, US - Received
- June 7, 1990
- Decision date
- September 5, 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 |
|---|---|---|
| K943252 | Pro-Step LH Ovulation Prediction TestCEP · Traditional | 10/25/1994SE |
| K925303 | Pro-Step PT HCGJHI · Traditional | 06/15/1993SE |
| K925125 | Pro-Step HCGJHI · Traditional | 01/13/1993SE |
| K911826 | Immunocard HCG One Step (I-S) Test KitJHI · Traditional | 07/19/1991SE |
| K903070 | Serocard HSV Igg Antibody Test KitLGC · Traditional | 08/09/1990SE |
| K895912 | Immunocard HCG Ii-S Test KitJHI · Traditional | 12/01/1989SE |
| K896109 | Immunocard Strep a TestGTZ · Traditional | 11/29/1989SE |
| K884249 | Modified Ddi Serocard Toxoplasma Igg Test KitLGD · Traditional | 04/10/1989SE |
| K884248 | Modified Ddi Serocard CMV Igg Test KitLFZ · Traditional | 04/10/1989SE |
| K884247 | Modified Ddi Serocard Rubella Igg Test KitLFX · Traditional | 04/10/1989SE |
Questions and answers
When was Modification of Serocard Rubella Igg Test cleared by the FDA?
Modification of Serocard Rubella Igg Test (K902571) received a 510(k) decision of Substantially Equivalent on September 5, 1990, 90 days after the submission was received.
What is the product code of K902571?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.