ONLINE TDM Vancomycin Gen.3
FDA 510(k) K152245 · Roche Diagnostics Operations (Rdo)
510(k) numberK152245
Submission
- Device name
- ONLINE TDM Vancomycin Gen.3
- Applicant
- Roche Diagnostics Operations (Rdo)
Indianapolis, IN, US - Received
- August 10, 2015
- Decision date
- January 8, 2016
- 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 |
| K020692 | Emit 2000 Vancomycin AssayLEH · Traditional | Dade Behring, Inc. | 05/10/2002SE |
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Questions and answers
When was ONLINE TDM Vancomycin Gen.3 cleared by the FDA?
ONLINE TDM Vancomycin Gen.3 (K152245) received a 510(k) decision of Substantially Equivalent on January 8, 2016, 151 days after the submission was received.
What is the product code of K152245?
The FDA product code is LEH – Radioimmunoassay, Vancomycin, a Class II (moderate risk) device regulated under 21 CFR 862.3950.