Human Cystatin C Kit for Use on Modular P Analyser
FDA 510(k) K080384 · The Binding Site, Ltd.
510(k) numberK080384
Submission
- Device name
- Human Cystatin C Kit for Use on Modular P Analyser
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- February 13, 2008
- Decision date
- June 6, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NDY – Test, Cystatin C
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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Questions and answers
When was Human Cystatin C Kit for Use on Modular P Analyser cleared by the FDA?
Human Cystatin C Kit for Use on Modular P Analyser (K080384) received a 510(k) decision of Substantially Equivalent on June 6, 2008, 114 days after the submission was received.
What is the product code of K080384?
The FDA product code is NDY – Test, Cystatin C, a Class II (moderate risk) device regulated under 21 CFR 862.1225.