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Medical Electronic Systems, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243114SQA-iOw Sperm Quality AnalyzerMay 2, 2025
K241628YO Home Sperm TestNovember 29, 2024
K220828SQA-iO Sperm Quality AnalyzerAugust 7, 2023
K161493YO Home Sperm TestNovember 8, 2016
K063864QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSISMarch 26, 2007
K021746SQA V, SPERM QUALITY ANALYZERSeptember 20, 2002
K012352SQA, SPERM QUALITY ANALYZERSeptember 21, 2001