ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS— 510(k) K111960
Substantially EquivalentElitechgroup
FDA 510(k) clearance K111960 for ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS, Substantially Equivalent on 2011-11-18. Applicant: Elitechgroup. Device class: 2.
Clearance details
- Applicant
- Elitechgroup
- Product code
- Code KHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Recent devices under product code KHS
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Data sourced from openFDA. This site is unofficial and independent of the FDA.