Dimension Cyclosporine Extended Range Calibrator (DC108A)
FDA 510(k) K061503 · Dade Behring, Inc.
510(k) numberK061503
Submission
- Device name
- Dimension Cyclosporine Extended Range Calibrator (DC108A)
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- June 1, 2006
- Decision date
- June 22, 2006
- 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 Cyclosporine Extended Range Calibrator (DC108A) cleared by the FDA?
Dimension Cyclosporine Extended Range Calibrator (DC108A) (K061503) received a 510(k) decision of Substantially Equivalent on June 22, 2006, 21 days after the submission was received.
What is the product code of K061503?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.