HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER— 510(k) K080384
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K080384 for HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER, Substantially Equivalent on 2008-06-06. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code NDY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.