Clue Birth Control
Device, Fertility Diagnostic, Contraceptive, Software Application
BioWink GmbH
The following data is part of a premarket notification filed by Biowink Gmbh with the FDA for Clue Birth Control.
Pre-market Notification Details
| Device ID | K193330 |
| 510k Number | K193330 |
| Device Name: | Clue Birth Control |
| Classification | Device, Fertility Diagnostic, Contraceptive, Software Application |
| Applicant | BioWink GmbH Adalbertstrasse 7-8 Berlin, DE 10999 |
| Contact | Georgina Denis |
| Correspondent | Yarmela Pavlovic BioWink GmbH One Embarcadero Center 30th Floor San Francisco, CA 94111 |
| Product Code | PYT |
| CFR Regulation Number | 884.5370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2021-02-18 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260749840008 | K193330 | 000 |
Trademark Results [Clue Birth Control]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLUE BIRTH CONTROL 79326011 not registered Live/Pending |
BioWink GmbH 2021-09-07 |
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