FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K032874 |
BIOCOAT, INC. |
HBA SPERM-HYALURONAN BINDING ASSAY |
11/24/2003 |
K024337 |
BIOSHAF LTD. |
GENERAL SEMEN ANALYSIS (GSA) KIT |
07/03/2003 |
K202089 |
Bonraybio Co., Ltd. |
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer |
10/28/2020 |
K180343 |
Bonraybio Co., Ltd. |
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer |
11/16/2018 |
K071737 |
DYN-BIOSHAF (2006) LTD. |
GENERAL SEMEN ANALYSIS KIT |
10/25/2007 |
K011679 |
EMBRYOTECH LABORATORIES, INC. |
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY |
08/15/2001 |
K983473 |
EMBRYOTECH LABORATORIES, INC. |
FERTILMARQ TEST KIT |
12/17/1998 |
K041039 |
GENOSIS LTD. |
FERTELL MALE FERTILITY TEST |
07/20/2004 |
K012805 |
HAMILTON THORNE RESEARCH |
AUTOMARQER |
03/13/2002 |
K990184 |
HAMILTON THORNE RESEARCH |
AUTOMARQER |
03/19/1999 |
K220828 |
Medical Electronic Systems LTD |
SQA-iO Sperm Quality Analyzer |
08/07/2023 |
K063864 |
MEDICAL ELECTRONIC SYSTEMS LTD. |
QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS |
03/26/2007 |
K021746 |
MEDICAL ELECTRONIC SYSTEMS, LLC |
SQA V, SPERM QUALITY ANALYZER |
09/20/2002 |
K012352 |
MEDICAL ELECTRONIC SYSTEMS, LLC |
SQA, SPERM QUALITY ANALYZER |
09/21/2001 |
K161493 |
MEDICAL ELECTRONIC SYSTEMS, LTD |
YO Home Sperm Test |
11/08/2016 |
K183602 |
MotilityCount ApS |
SwimCount Sperm Quality Test |
06/27/2019 |
K100341 |
PRINCETON BIOMEDITECH CORP. |
SPERMCHECK FERTILITY |
05/04/2010 |
K073039 |
PRINCETON BIOMEDITECH CORP. |
SPERMCHECK VASECTOMY |
01/24/2008 |
K153683 |
SANDSTONE DIAGNOSTICS, INC. |
Trak Male Fertility Testing System |
05/16/2016 |
K172514 |
Sandstone Diagnostics, Inc. |
Trak Plus Male Fertility Testing System |
11/17/2017 |