The following data is part of a premarket notification filed by Bd Diagnostics Science with the FDA for Bd Geneohm Vanr Assay.
| Device ID | K102416 |
| 510k Number | K102416 |
| Device Name: | BD GENEOHM VANR ASSAY |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
| Applicant | BD DIAGNOSTICS SCIENCE 7 LOVETON CIRCLE MAIL CODE 614 Sparks, MD 21152 |
| Contact | Raymond Boule |
| Correspondent | Raymond Boule BD DIAGNOSTICS SCIENCE 7 LOVETON CIRCLE MAIL CODE 614 Sparks, MD 21152 |
| Product Code | NIJ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-24 |
| Decision Date | 2011-10-20 |
| Summary: | summary |