The following data is part of a premarket notification filed by Genosis, Inc. with the FDA for Fertell Female Fertility Test.
| Device ID | K032002 |
| 510k Number | K032002 |
| Device Name: | FERTELL FEMALE FERTILITY TEST |
| Classification | Test, Follicle Stimulating Hormone (fsh), Over The Counter |
| Applicant | GENOSIS, INC. 1111 PENNSYLVANIA AVE,NW Washington,, DC 20004 |
| Contact | Sharon A Segal |
| Correspondent | Sharon A Segal GENOSIS, INC. 1111 PENNSYLVANIA AVE,NW Washington,, DC 20004 |
| Product Code | NGA |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-27 |
| Decision Date | 2003-10-30 |
| Summary: | summary |