Tacrolimus Assay Kit
FDA 510(k) K203833 · Shanghai Genext Medical Technology Co., Ltd.
510(k) numberK203833
Submission
- Device name
- Tacrolimus Assay Kit
- Applicant
- Shanghai Genext Medical Technology Co., Ltd.
Shanghai, CN - Received
- December 30, 2020
- Decision date
- January 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLM – Enzyme Immunoassay, Tracrolimus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1678
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MLM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K173857 | Elecsys TacrolimusMLM · Traditional | Roche Diagnostics | 11/06/2018SE |
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC…MLM · Traditional | Siemens Healthcare Diagnostics | 11/04/2015SE |
| K123343 | Thermo Scientific QMS Tacrolimus Assay and CalibratorsMLM · Traditional | Microgenics Corp. | 07/11/2013SE |
| K070820 | Architect Tacrolimus: Model 1L77MLM · Traditional | Fujirebio Diagnostics,Inc. | 08/01/2007SE |
| K063868 | Masstrak Immunosuppressants KitMLM · Traditional | Waters Corporation | 05/25/2007SE |
| K060502 | Dimension Tacr Flex Reagent Cartridge, Model DF107MLM · Traditional | Dade Behring, Inc. | 05/18/2006SE |
| K060385 | Emit 2000 Tacrolimus Assay and Sample Pretreatment ReagentMLM · Traditional | Dade Behring, Inc. | 04/06/2006SE |
| K050206 | Cedia Tacrolimus AssayMLM · Traditional | Microgenics Corp. | 03/15/2005SE |
Questions and answers
When was Tacrolimus Assay Kit cleared by the FDA?
Tacrolimus Assay Kit (K203833) received a 510(k) decision of Substantially Equivalent on January 27, 2023, 758 days after the submission was received.
What is the product code of K203833?
The FDA product code is MLM – Enzyme Immunoassay, Tracrolimus, a Class II (moderate risk) device regulated under 21 CFR 862.1678.