FDA Product Code
FDA Product Code POV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5220
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252228 | Seaman Pro/Seaman | Checkcells, Inc. | 2026-04-09 | Traditional | PDF ↗ |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | 2025-05-30 | Traditional | PDF ↗ |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | 2025-05-09 | Traditional | PDF ↗ |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2025-05-02 | Dual Track | PDF ↗ |
| K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2024-11-29 | Traditional | PDF ↗ |
| K220828 | SQA-iO Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2023-08-07 | Traditional | PDF ↗ |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | 2020-10-28 | Special | PDF ↗ |
| K183602 | SwimCount Sperm Quality Test | Motilitycount Aps | 2019-06-27 | Traditional | PDF ↗ |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | 2018-11-16 | Traditional | PDF ↗ |
| K172514 | Trak Plus Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2017-11-17 | Traditional | PDF ↗ |
| K161493 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2016-11-08 | Traditional | PDF ↗ |
| K153683 | Trak Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2016-05-16 | Traditional | PDF ↗ |
| K100341 | SPERMCHECK FERTILITY | Princeton BioMeditech Corp. | 2010-05-04 | Traditional | PDF ↗ |
| K073039 | SPERMCHECK VASECTOMY | Princeton BioMeditech Corp. | 2008-01-24 | Traditional | PDF ↗ |
| K071737 | GENERAL SEMEN ANALYSIS KIT | Dyn-Bioshaf (2006) , Ltd. | 2007-10-25 | Traditional | PDF ↗ |
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | Medical Electronic Systems , Ltd. | 2007-03-26 | Traditional | PDF ↗ |
| K041039 | FERTELL MALE FERTILITY TEST | Genosis , Ltd. | 2004-07-20 | Traditional | PDF ↗ |
| K032874 | HBA SPERM-HYALURONAN BINDING ASSAY | Biocoat, Inc. | 2003-11-24 | Traditional | PDF ↗ |
| K024337 | GENERAL SEMEN ANALYSIS (GSA) KIT | Bioshaf , Ltd. | 2003-07-03 | Traditional | PDF ↗ |
| K021746 | SQA V, SPERM QUALITY ANALYZER | Medical Electronic Systems, LLC | 2002-09-20 | Traditional | PDF ↗ |
| K012805 | AUTOMARQER | Hamilton Thorne Research | 2002-03-13 | Traditional | PDF ↗ |
| K012352 | SQA, SPERM QUALITY ANALYZER | Medical Electronic Systems, LLC | 2001-09-21 | Traditional | PDF ↗ |
| K011679 | FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY | Embryotech Laboratories, Inc. | 2001-08-15 | Traditional | PDF ↗ |
| K990184 | AUTOMARQER | Hamilton Thorne Research | 1999-03-19 | Traditional | PDF ↗ |
| K983473 | FERTILMARQ TEST KIT | Embryotech Laboratories, Inc. | 1998-12-17 | Traditional | PDF ↗ |
| K915229 | SEMEN ANALYSIS KIT | Humagen Fertility Diagnostics, Inc. | 1994-08-30 | Traditional | PDF ↗ |
| K894949 | SQA | United Medical Systems, Inc. | 1989-12-29 | Traditional | PDF ↗ |
| K881765 | CTS-3060 AUTOMATED SEMEN ANALYZER | Motion Analysis Corp. | 1989-02-15 | Traditional | PDF ↗ |
Product code POV · Class II · Hematology. Data: openFDA.