The following data is part of a premarket notification filed by Gryphus Diagnostics, Llc with the FDA for Modification To Bvblue.
| Device ID | K050755 |
| 510k Number | K050755 |
| Device Name: | MODIFICATION TO BVBLUE |
| Classification | Test, Vaginal, Bacterial Sialidase |
| Applicant | GRYPHUS DIAGNOSTICS, LLC 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Contact | Thomas M Tsakeris |
| Correspondent | Thomas M Tsakeris GRYPHUS DIAGNOSTICS, LLC 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Product Code | MXB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-23 |
| Decision Date | 2005-04-06 |