The following data is part of a premarket notification filed by Fertility Solutions, Inc. with the FDA for Semen Analysis Quality Control, Assayed And Unassayed.
| Device ID | K041240 |
| 510k Number | K041240 |
| Device Name: | SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED |
| Classification | Material, Quality Control, Semen Analysis |
| Applicant | FERTILITY SOLUTIONS, INC. 13000 SHAKER BLVD. Cleveland, OH 44120 |
| Contact | Susan A Rothmann, Ph.d., Hcld |
| Correspondent | Susan A Rothmann, Ph.d., Hcld FERTILITY SOLUTIONS, INC. 13000 SHAKER BLVD. Cleveland, OH 44120 |
| Product Code | NRF |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-11 |
| Decision Date | 2004-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509001898 | K041240 | 000 |
| 00844509001867 | K041240 | 000 |