Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
FDA 510(k) K150168 · Siemens Healthcare Diagnostics
510(k) numberK150168
Submission
- Device name
- Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- January 26, 2015
- Decision date
- November 4, 2015
- 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
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| K123343 | Thermo Scientific QMS Tacrolimus Assay and CalibratorsMLM · Traditional | Microgenics Corp. | 07/11/2013SE |
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| 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 Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) cleared by the FDA?
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) (K150168) received a 510(k) decision of Substantially Equivalent on November 4, 2015, 282 days after the submission was received.
What is the product code of K150168?
The FDA product code is MLM – Enzyme Immunoassay, Tracrolimus, a Class II (moderate risk) device regulated under 21 CFR 862.1678.