LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
FDA Regulatory Profile
Summary
- Total Recalls
- 2 (2 Class I)
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1620-2021 | Class I | Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. fo | April 26, 2021 |
| Z-1619-2021 | Class I | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. | April 26, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K172331 | Type I, Type II, Type III, Type IV | March 2, 2018 |
| K172099 | Shoocin Introducer Kit | October 5, 2017 |
| K141707 | ULTRASKIN HYDROPHILIC GUIDE WIRE | January 21, 2015 |
| K142359 | Vasc Band hemostat | October 23, 2014 |
| K123475 | SHOOCIN INTRODUCER KIT | February 3, 2014 |
| K123473 | HOPER PTCA BALLOON CATHETER | August 13, 2013 |
| K111837 | RADIAL ARTERY COMPRESSION TOURNIQUET | September 27, 2011 |