K063864 is an FDA 510(k) clearance for the QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS. This device is classified as a Semen Analysis Device (Class II - Special Controls, product code POV).
Submitted by Medical Electronic Systems , Ltd. (Los Angeles, US). The FDA issued a Cleared decision on March 26, 2007, 87 days after receiving the submission on December 29, 2006.
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 | K063864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2006 |
| Decision Date | March 26, 2007 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| 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. |