Dimension Vista System Enzyme 5 Calibrator, Model KC350
FDA 510(k) K083462 · Siemens Healthcare Diagnostics
510(k) numberK083462
Submission
- Device name
- Dimension Vista System Enzyme 5 Calibrator, Model KC350
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- November 24, 2008
- Decision date
- February 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
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Questions and answers
When was Dimension Vista System Enzyme 5 Calibrator, Model KC350 cleared by the FDA?
Dimension Vista System Enzyme 5 Calibrator, Model KC350 (K083462) received a 510(k) decision of Substantially Equivalent on February 27, 2009, 95 days after the submission was received.
What is the product code of K083462?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.