Dimension Clinical Chemistry System Enzyme I Calibrator
FDA 510(k) K081789 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK081789
Submission
- Device name
- Dimension Clinical Chemistry System Enzyme I Calibrator
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Newark, DE, US - Received
- June 25, 2008
- Decision date
- September 10, 2008
- 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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Questions and answers
When was Dimension Clinical Chemistry System Enzyme I Calibrator cleared by the FDA?
Dimension Clinical Chemistry System Enzyme I Calibrator (K081789) received a 510(k) decision of Substantially Equivalent on September 10, 2008, 77 days after the submission was received.
What is the product code of K081789?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.