The following data is part of a premarket notification filed by Geneohm Sciences Canada, Inc. (bd Diagnostics) with the FDA for Bd Max Vaginal Panel.
| Device ID | K191957 |
| 510k Number | K191957 |
| Device Name: | BD MAX Vaginal Panel |
| Classification | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
| Applicant | GeneOhm Sciences Canada, Inc. (BD Diagnostics) 2555 Boul. Du Parc-Technologique Quebec, CA Gip 4s5 |
| Contact | Katie Edwards |
| Correspondent | Katie Edwards GeneOhm Sciences Canada, Inc. (BD Diagnostics) 2555 Boul. Du Parc-Technologique Quebec, CA Gip 4s5 |
| Product Code | PQA |
| CFR Regulation Number | 866.3975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-23 |
| Decision Date | 2019-10-21 |