The following data is part of a premarket notification filed by Quantrx Biomedical Corporation with the FDA for Quantrx Female Fertility Test.
| Device ID | K070484 |
| 510k Number | K070484 |
| Device Name: | QUANTRX FEMALE FERTILITY TEST |
| Classification | Test, Follicle Stimulating Hormone (fsh), Over The Counter |
| Applicant | QUANTRX BIOMEDICAL CORPORATION 14033 STONEY GATE PLACE San Diego, CA 92128 |
| Contact | Lorraine C Cogan |
| Correspondent | Lorraine C Cogan QUANTRX BIOMEDICAL CORPORATION 14033 STONEY GATE PLACE San Diego, CA 92128 |
| Product Code | NGA |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-10-22 |
| Summary: | summary |