510(k) K011679
- Device
- FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
- Applicant
- EMBRYOTECH LABORATORIES, INC.
- 510(k) number
- K011679
- Product code
- POV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-15
- Date received
- 2001-05-30
- Regulation
- 864.5220
- Classification name
- Semen Analysis Device
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANN D MCGONIGLE
- Address
- 19 Sedgemeadow Rd. Wayland MA US 01778 01778
FDA Registration Numbers#
- 1216677
- 3003646592
- 3015550658
- 3007800906
- 2246703
- 3005360469
- 1221433
- 3016090200
- 3011260354
- 1832894
- 3014295858
- 3014053517
- 3043196750
Source Documents#
Other 510(k) Records For Product Code POV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | 2025-05-30 |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | 2025-05-09 |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2025-05-02 |
| K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2024-11-29 |
| K220828 | SQA-iO Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2023-08-07 |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | 2020-10-28 |
| K183602 | SwimCount Sperm Quality Test | Motilitycount Aps | 2019-06-27 |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | 2018-11-16 |
| K172514 | Trak Plus Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2017-11-17 |
| K161493 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2016-11-08 |
| K153683 | Trak Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2016-05-16 |
| K100341 | SPERMCHECK FERTILITY | Princeton BioMeditech Corp. | 2010-05-04 |
| K073039 | SPERMCHECK VASECTOMY | Princeton BioMeditech Corp. | 2008-01-24 |
| K071737 | GENERAL SEMEN ANALYSIS KIT | Dyn-Bioshaf (2006) , Ltd. | 2007-10-25 |
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | Medical Electronic Systems , Ltd. | 2007-03-26 |
Legacy Summary#
summary
FDA Review#
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