Rubella Virus Immunological Test System
FDA 510(k) K911444 · Wampole Laboratories
510(k) numberK911444
Submission
- Device name
- Rubella Virus Immunological Test System
- Applicant
- Wampole Laboratories
Cranbury, NJ, US - Received
- April 1, 1991
- Decision date
- August 30, 1991
- 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 |
|---|---|---|
| K965131 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 03/26/1997SE |
| K965129 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | 03/26/1997SE |
| K882896 | One-Step HCGDHA · Traditional | 10/31/1988SE |
| K883004 | Mono-Plus(Tm)KTN · Traditional | 08/04/1988SE |
| K875101 | Virogen CMV Antibody TestLQO · Traditional | 03/01/1988SE |
| K875161 | Mat (TM) Microalbumin TestDCF · Traditional | 02/17/1988SE |
| K791309 | Ucg-LyphotestJHJ · Traditional | 07/30/1979SE |
| K790986 | RF ControlsDMR · Traditional | 06/28/1979SE |
| K781794 | Beta-TecJHI · Traditional | 12/29/1978SE |
| K760336 | Biocept-GJHI · Traditional | 11/12/1976SE |
Questions and answers
When was Rubella Virus Immunological Test System cleared by the FDA?
Rubella Virus Immunological Test System (K911444) received a 510(k) decision of Substantially Equivalent on August 30, 1991, 151 days after the submission was received.
What is the product code of K911444?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.