The following data is part of a premarket notification filed by Bioself, Inc. with the FDA for Bioself 101.
| Device ID | K823209 |
| 510k Number | K823209 |
| Device Name: | BIOSELF 101 |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | BIOSELF, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-28 |
| Decision Date | 1983-02-15 |