The following data is part of a premarket notification filed by Embryotech Laboratories, Inc. with the FDA for Fertilmarq Home Diagnostic Screening Test Kit For Male Infertility.
| Device ID | K011679 |
| 510k Number | K011679 |
| Device Name: | FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY |
| Classification | Semen Analysis Device |
| Applicant | EMBRYOTECH LABORATORIES, INC. 19 SEDGEMEADOW RD. Wayland, MA 01778 |
| Contact | Ann D Mcgonigle |
| Correspondent | Ann D Mcgonigle EMBRYOTECH LABORATORIES, INC. 19 SEDGEMEADOW RD. Wayland, MA 01778 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-30 |
| Decision Date | 2001-08-15 |
| Summary: | summary |