Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01
FDA 510(k) K072036 · Biokit, S.A.
510(k) numberK072036
Submission
- Device name
- Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01
- Applicant
- Biokit, S.A.
Barcelona, ES - Received
- July 25, 2007
- Decision date
- March 19, 2008
- 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 |
| 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 |
| 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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| K132400 | Lp(A) Calibrators, and Lp(A) ControlsJIT · Abbreviated | 12/19/2013SE |
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Questions and answers
When was Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01 cleared by the FDA?
Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01 (K072036) received a 510(k) decision of Substantially Equivalent on March 19, 2008, 238 days after the submission was received.
What is the product code of K072036?
The FDA product code is LEH – Radioimmunoassay, Vancomycin, a Class II (moderate risk) device regulated under 21 CFR 862.3950.