510(k) K071219
- Device
- ATHENA MULTI-LYTE GBM TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- 510(k) number
- K071219
- Product code
- MVJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-06
- Date received
- 2007-05-02
- 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
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- EWA NADOLCZAK
- Address
- 200 Evans Way Branchburg NJ US 08876 08876
FDA Registration Numbers#
- 8043792
- 2026994
- 3007361513
- 3039353646
- 3012348571
- 3003268355
- 3032705
- 2242436
- 3004973408
- 3003935253
- 9610566
- 3015376545
- 3007118747
- 2915274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MVJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072358 | BIOPLEX VASCULITIS KIT | Bio-Rad Laboratories | 2007-10-31 |
| 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 |