FDA Product Code
FDA Product Code MVJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | Zeus Scientific, Inc. | 2007-12-06 | Traditional | PDF ↗ |
| K072358 | BIOPLEX VASCULITIS KIT | Bio-Rad Laboratories | 2007-10-31 | Traditional | PDF ↗ |
| K011348 | PHASE II GBM IGG ANTIBODY EIA TEST | Scimedx Corp. | 2001-06-25 | Traditional | PDF ↗ |
| K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | Cogent Diagnotics , Ltd. | 1999-08-09 | Traditional | PDF ↗ |
| K984619 | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-23 | Traditional | PDF ↗ |
| K984336 | QUANTA LITE GBM ELISA | Inova Diagnostics, Inc. | 1999-02-08 | Traditional | PDF ↗ |
Product code MVJ · Class II · Immunology. Data: openFDA.