K073039 is an FDA 510(k) clearance for the SPERMCHECK VASECTOMY. 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 January 24, 2008, 87 days after receiving the submission on October 29, 2007.
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 | K073039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2007 |
| Decision Date | January 24, 2008 |
| Days to Decision | 87 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. |