Dimension Vista Total Iron Binding Capacity Calibrator
FDA 510(k) K061251 · Dade Behring, Inc.
510(k) numberK061251
Submission
- Device name
- Dimension Vista Total Iron Binding Capacity Calibrator
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- May 4, 2006
- Decision date
- May 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIS – Calibrator, Primary
- 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 Total Iron Binding Capacity Calibrator cleared by the FDA?
Dimension Vista Total Iron Binding Capacity Calibrator (K061251) received a 510(k) decision of Substantially Equivalent on May 31, 2006, 27 days after the submission was received.
What is the product code of K061251?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.