Captia(R) Rubella-G
FDA 510(k) K883924 · Mercia Diagnostics , Ltd.
510(k) numberK883924
Submission
- Device name
- Captia(R) Rubella-G
- Applicant
- Mercia Diagnostics , Ltd.
Guildford, Surrey England, GB - Received
- September 16, 1988
- Decision date
- August 15, 1989
- 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 |
|---|---|---|
| K915479 | Captia Cmv-TaLFZ · Traditional | 05/04/1992SE |
| K904524 | Captia(R) Syphilis M, ModificationLIP · Traditional | 12/26/1990SE |
| K900654 | Modified Captia(R) Syphilis-MLIP · Traditional | 03/08/1990SE |
| K900655 | Modified Captia(R) Toxo-MLGD · Traditional | 03/06/1990SE |
| K896295 | Captia(R) Cmv-MLFZ · Traditional | 03/06/1990SE |
| K896194 | Captia(R) Cmv-GLFZ · Traditional | 03/06/1990SE |
| K885300 | Captia(R) Rubella-MLFX · Traditional | 08/15/1989SE |
| K892802 | Super DuoJWZ · Traditional | 06/13/1989SE |
| K881425 | Captia(R) Syphilis-GLIP · Traditional | 08/04/1988SE |
| K880918 | Captia Toxo-GLGD · Traditional | 08/01/1988SE |
Questions and answers
When was Captia(R) Rubella-G cleared by the FDA?
Captia(R) Rubella-G (K883924) received a 510(k) decision of Substantially Equivalent on August 15, 1989, 333 days after the submission was received.
What is the product code of K883924?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.