The following data is part of a premarket notification filed by Humagen Fertility Diagnostics, Inc. with the FDA for Semen Analysis Kit.
| Device ID | K915229 |
| 510k Number | K915229 |
| Device Name: | SEMEN ANALYSIS KIT |
| Classification | Semen Analysis Device |
| Applicant | Humagen FERTILITY DIAGNOSTICS, INC. 2345 HUNTER'S WAY #2 Charlottesville, VA 22901 |
| Contact | Debra Bryant |
| Correspondent | Debra Bryant Humagen FERTILITY DIAGNOSTICS, INC. 2345 HUNTER'S WAY #2 Charlottesville, VA 22901 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-20 |
| Decision Date | 1994-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937900028 | K915229 | 000 |
| 60888937900011 | K915229 | 000 |
| 20888937911033 | K915229 | 000 |