Dimension Vista Digitoxin Calibrator - DGTX Cal
FDA 510(k) K103360 · Siemens Corp.
510(k) numberK103360
Submission
- Device name
- Dimension Vista Digitoxin Calibrator - DGTX Cal
- Applicant
- Siemens Corp.
Newark, DE, US - Received
- November 16, 2010
- Decision date
- December 17, 2010
- 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 Vista Digitoxin Calibrator - DGTX Cal cleared by the FDA?
Dimension Vista Digitoxin Calibrator - DGTX Cal (K103360) received a 510(k) decision of Substantially Equivalent on December 17, 2010, 31 days after the submission was received.
What is the product code of K103360?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.