510(k) K072358
- Device
- BIOPLEX VASCULITIS KIT
- Applicant
- Bio-Rad Laboratories
- 510(k) number
- K072358
- Product code
- MVJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-10-31
- Date received
- 2007-08-22
- Regulation
- 866.5660
- Classification name
- Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PRIYA BONDRE
- Address
- 6565 185th Ave., NE Redmond WA US 98052 98052
FDA Registration Numbers#
- 8043792
- 2026994
- 3012348571
- 3007118747
- 3003268355
- 3015376545
- 2242436
- 3003935253
- 9610566
- 3004973408
- 3039353646
- 2915274
- 3032705
- 3007361513
Source Documents#
Other 510(k) Records For Product Code MVJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | Zeus Scientific, Inc. | 2007-12-06 |
| K011348 | PHASE II GBM IGG ANTIBODY EIA TEST | Scimedx Corp. | 2001-06-25 |
| K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | Cogent Diagnotics , Ltd. | 1999-08-09 |
| K984619 | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-23 |
| K984336 | QUANTA LITE GBM ELISA | Inova Diagnostics, Inc. | 1999-02-08 |
Legacy Summary#
summary
FDA Review#
Decision Summary