Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent
FDA 510(k) K060385 · Dade Behring, Inc.
510(k) numberK060385
Submission
- Device name
- Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- February 14, 2006
- Decision date
- April 6, 2006
- 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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Questions and answers
When was Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent cleared by the FDA?
Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent (K060385) received a 510(k) decision of Substantially Equivalent on April 6, 2006, 51 days after the submission was received.
What is the product code of K060385?
The FDA product code is MLM – Enzyme Immunoassay, Tracrolimus, a Class II (moderate risk) device regulated under 21 CFR 862.1678.