Enzyme Immunoassay, Vancomycin
FDA 510(k) K060586 · Roche Diagnostics Corp.
510(k) numberK060586
Submission
- Device name
- Enzyme Immunoassay, Vancomycin
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- March 7, 2006
- Decision date
- May 11, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LEH – Radioimmunoassay, Vancomycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3950
- Specialty
- Clinical Toxicology
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| K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…LEH · Traditional | Ortho-Clinical Diagnostics, Inc. | 02/07/2005SE |
| K032811 | Cedia Vancomycin AssayLEH · Traditional | Microgenics Corp. | 11/24/2003SE |
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Questions and answers
When was Enzyme Immunoassay, Vancomycin cleared by the FDA?
Enzyme Immunoassay, Vancomycin (K060586) received a 510(k) decision of Substantially Equivalent on May 11, 2006, 65 days after the submission was received.
What is the product code of K060586?
The FDA product code is LEH – Radioimmunoassay, Vancomycin, a Class II (moderate risk) device regulated under 21 CFR 862.3950.