ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT— 510(k) K141265
Substantially EquivalentElitechgroup
FDA 510(k) clearance K141265 for ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT, Substantially Equivalent on 2014-07-18. Applicant: Elitechgroup. Device class: 2.
Clearance details
- Applicant
- Elitechgroup
- Product code
- Code JHW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.