Dimension Vista Csae Calibrator, Model KC440
FDA 510(k) K082030 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK082030
Submission
- Device name
- Dimension Vista Csae Calibrator, Model KC440
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Newark, DE, US - Received
- July 17, 2008
- Decision date
- August 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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Questions and answers
When was Dimension Vista Csae Calibrator, Model KC440 cleared by the FDA?
Dimension Vista Csae Calibrator, Model KC440 (K082030) received a 510(k) decision of Substantially Equivalent on August 22, 2008, 36 days after the submission was received.
What is the product code of K082030?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.