The Standard Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
The Standard Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Blue Eye, Blue Eye (TS-905)
2
Total
2
Cleared
0
Denied
The Standard Co., Ltd. has 2 FDA 510(k) cleared medical devices. Based in Gunpo-Si, KR.
Latest FDA clearance: Jul 2024. Active since 2022. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by The Standard Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by LK Consulting Group USA, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - The Standard Co., Ltd.
2 devices