Tacrolimus Assay Kit— 510(k) K203833
Substantially EquivalentShanghai Genext Medical Technology Co., Ltd.
FDA 510(k) clearance K203833 for Tacrolimus Assay Kit, Substantially Equivalent on 2023-01-27. Applicant: Shanghai Genext Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai Genext Medical Technology Co., Ltd.
- Product code
- Code MLM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1678
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code MLM
view allData sourced from openFDA. This site is unofficial and independent of the FDA.