Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System
FDA 510(k) K092587 · Bio-Rad Laboratories
510(k) numberK092587
Submission
- Device name
- Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System
- Applicant
- Bio-Rad Laboratories
Benicia, CA, US - Received
- August 24, 2009
- Decision date
- December 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFX – Enzyme Linked Immunoabsorbent Assay, Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
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|---|---|---|---|
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| K122397 | Liaison Rubella Igm, Liaison Control Rubella IgmLFX · Traditional | DiaSorin, Inc. | 09/06/2012SE |
| K093101 | Mago 4SLFX · Traditional | Diamedix Corp. | 01/21/2011SE |
| 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 |
| K063143 | Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and CalibratorsLFX · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/26/2006SE |
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Questions and answers
When was Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System cleared by the FDA?
Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System (K092587) received a 510(k) decision of Substantially Equivalent on December 3, 2010, 466 days after the submission was received.
What is the product code of K092587?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.