K100341 is an FDA 510(k) clearance for the SPERMCHECK FERTILITY. This device is classified as a Semen Analysis Device (Class II - Special Controls, product code POV).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 4, 2010, 88 days after receiving the submission on February 5, 2010.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220. Device Used To Evaluate One Or More Human Semen Parameters Including Semen Volume, Sperm Concentration, Total Sperm Number, Sperm Motility, Sperm Morphology, Sperm Vitality, White Blood Cell Concentration, And Ph..
| 510(k) Number | K100341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2010 |
| Decision Date | May 04, 2010 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | POV — Semen Analysis Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |
| Definition | Device Used To Evaluate One Or More Human Semen Parameters Including Semen Volume, Sperm Concentration, Total Sperm Number, Sperm Motility, Sperm Morphology, Sperm Vitality, White Blood Cell Concentration, And Ph. |