Dimension Clinical Chemistry System
FDA 510(k) K112999 · Siemens Healthcare Diagnostics
510(k) numberK112999
Submission
- Device name
- Dimension Clinical Chemistry System
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- October 7, 2011
- Decision date
- November 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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Questions and answers
When was Dimension Clinical Chemistry System cleared by the FDA?
Dimension Clinical Chemistry System (K112999) received a 510(k) decision of Substantially Equivalent on November 22, 2011, 46 days after the submission was received.
What is the product code of K112999?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.