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 |