Thermo Scientific QMS Tacrolimus Assay and Calibrators
FDA 510(k) K123343 · Microgenics Corp.
510(k) numberK123343
Submission
- Device name
- Thermo Scientific QMS Tacrolimus Assay and Calibrators
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- October 31, 2012
- Decision date
- July 11, 2013
- 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 |
|---|---|---|---|
| K203833 | Tacrolimus Assay KitMLM · Traditional | Shanghai Genext Medical Technology Co., Ltd. | 01/27/2023SE |
| 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 |
| 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 |
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Questions and answers
When was Thermo Scientific QMS Tacrolimus Assay and Calibrators cleared by the FDA?
Thermo Scientific QMS Tacrolimus Assay and Calibrators (K123343) received a 510(k) decision of Substantially Equivalent on July 11, 2013, 253 days after the submission was received.
What is the product code of K123343?
The FDA product code is MLM – Enzyme Immunoassay, Tracrolimus, a Class II (moderate risk) device regulated under 21 CFR 862.1678.