The following data is part of a premarket notification filed by Fertil-a-chron, Inc. with the FDA for Biochron Fertility Indicator.
| Device ID | K852801 |
| 510k Number | K852801 |
| Device Name: | BIOCHRON FERTILITY INDICATOR |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | FERTIL-A-CHRON, INC. 350 MOTOR PKWY. Hauppauge, NY 11788 |
| Contact | Russell J Varano |
| Correspondent | Russell J Varano FERTIL-A-CHRON, INC. 350 MOTOR PKWY. Hauppauge, NY 11788 |
| 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 | 1985-07-01 |
| Decision Date | 1985-09-19 |