Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers I, II and III
FDA 510(k) K043386 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK043386
Submission
- Device name
- Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers I, II and III
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- December 9, 2004
- Decision date
- February 7, 2005
- 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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|---|---|---|---|
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)LEH · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/08/2023SE |
| K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)LEH · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/27/2016SE |
| K152245 | ONLINE TDM Vancomycin Gen.3LEH · Traditional | Roche Diagnostics Operations (Rdo) | 01/08/2016SE |
| K123947 | Architect IvancomycinLEH · Traditional | Biokit, S.A. | 08/29/2013SE |
| K072036 | Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25…LEH · Traditional | Biokit, S.A. | 03/19/2008SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | Diagnostic Products Corp. | 12/05/2006SE |
| K060586 | Enzyme Immunoassay, VancomycinLEH · Traditional | Roche Diagnostics Corp. | 05/11/2006SE |
| K050419 | QMS VancomycinLEH · Traditional | Seradyn, Inc. | 04/01/2005SE |
| 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 Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers I, II and III cleared by the FDA?
Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers I, II and III (K043386) received a 510(k) decision of Substantially Equivalent on February 7, 2005, 60 days after the submission was received.
What is the product code of K043386?
The FDA product code is LEH – Radioimmunoassay, Vancomycin, a Class II (moderate risk) device regulated under 21 CFR 862.3950.