The following data is part of a premarket notification filed by Genosis Ltd. with the FDA for Fertell Male Fertility Test.
| Device ID | K041039 |
| 510k Number | K041039 |
| Device Name: | FERTELL MALE FERTILITY TEST |
| Classification | Semen Analysis Device |
| Applicant | GENOSIS LTD. 1111 PENNSYLVANIA AVE. N.W. Washington, DC 20004 |
| Contact | Sharon A Segal |
| Correspondent | Sharon A Segal GENOSIS LTD. 1111 PENNSYLVANIA AVE. N.W. Washington, DC 20004 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-22 |
| Decision Date | 2004-07-20 |
| Summary: | summary |