MVJ — Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) Class II
FDA Device Classification
Classification Details
- Product Code
- MVJ
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K071219 | zeus scientific | ATHENA MULTI-LYTE GBM TEST SYSTEM | December 6, 2007 |
| K072358 | bio-rad laboratories | BIOPLEX VASCULITIS KIT | October 31, 2007 |
| K011348 | scimedx | PHASE II GBM IGG ANTIBODY EIA TEST | June 25, 2001 |
| K991890 | cogent diagnotics | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | August 9, 1999 |
| K984619 | binding site | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT | February 23, 1999 |
| K984336 | inova diagnostics | QUANTA LITE GBM ELISA | February 8, 1999 |