Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con H
FDA 510(k) K110169 · Siemens Healthcare Diagnostics
510(k) numberK110169
Submission
- Device name
- Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con H
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- January 20, 2011
- Decision date
- April 7, 2011
- 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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| 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 CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con H cleared by the FDA?
Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con H (K110169) received a 510(k) decision of Substantially Equivalent on April 7, 2011, 77 days after the submission was received.
What is the product code of K110169?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.