ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL— 510(k) K132399
Substantially EquivalentElitechgroup
FDA 510(k) clearance K132399 for ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL, Substantially Equivalent on 2014-01-03. Applicant: Elitechgroup. Device class: 2.
Clearance details
- Applicant
- Elitechgroup
- Product code
- Code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- 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.