NRF
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Material, Quality Control, Semen Analysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Medical specialty
- Hematology
- FDA definition
- A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QC-BEADS (K042750) | Bioscreen, Inc. | 2004-10-29 |
| QWIKCHECK-BEADS (K041600) | Medical Electronics Systems , Ltd. | 2004-07-27 |
| SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED (K041240) | Fertility Solutions, Inc. | 2004-06-02 |
Track NRF automatically
Every clearance here is in the API, with alerts when new ones post.