The following data is part of a premarket notification filed by Visby Medical with the FDA for Visby Medical Sexual Health.
| Device ID | K200748 |
| 510k Number | K200748 |
| Device Name: | Visby Medical Sexual Health |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Visby Medical 3010 N. First Street San Jose, CA 95134 |
| Contact | Carolyn Glickman |
| Correspondent | Beth Lingenfelter Visby Medical 3010 North First Street San Jose, CA 95134 |
| Product Code | QEP |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | OUY |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-23 |
| Decision Date | 2021-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810031720057 | K200748 | 000 |
| 00810031720033 | K200748 | 000 |
| 00810031720002 | K200748 | 000 |
| 00810031720071 | K200748 | 000 |
| 10810031720061 | K200748 | 000 |