Bioplex Vasculitis Kit
FDA 510(k) K072358 · Bio-Rad Laboratories
510(k) numberK072358
Submission
- Device name
- Bioplex Vasculitis Kit
- Applicant
- Bio-Rad Laboratories
Redmond, WA, US - Received
- August 22, 2007
- Decision date
- October 31, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MVJ – Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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|---|---|---|---|
| K071219 | Athena Multi-Lyte GBM Test SystemMVJ · Traditional | Zeus Scientific, Inc. | 12/06/2007SE |
| K011348 | Phase II GBM Igg Antibody Eia TestMVJ · Traditional | Scimedx Corp. | 06/25/2001SE |
| K991890 | Autostat II Anti-Gbm Elisa, Hy.Tec Anti-Gmb ElisaMVJ · Traditional | Cogent Diagnotics , Ltd. | 08/09/1999SE |
| K984619 | Binding Site Bindazyme Anti-Gbm Eia Diagnostic Test KitMVJ · Traditional | The Binding Site, Ltd. | 02/23/1999SE |
| K984336 | Quanta Lite GBM ElisaMVJ · Traditional | Inova Diagnostics, Inc. | 02/08/1999SE |
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Questions and answers
When was Bioplex Vasculitis Kit cleared by the FDA?
Bioplex Vasculitis Kit (K072358) received a 510(k) decision of Substantially Equivalent on October 31, 2007, 70 days after the submission was received.
What is the product code of K072358?
The FDA product code is MVJ – Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm), a Class II (moderate risk) device regulated under 21 CFR 866.5660.