ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...— 510(k) K102647
Substantially EquivalentElitechgroup Vital Scientific BV
FDA 510(k) clearance K102647 for ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE..., Substantially Equivalent on 2011-03-24. Applicant: Elitechgroup Vital Scientific BV.
Clearance details
- Applicant
- Elitechgroup Vital Scientific BV
- Product code
- Code JGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Adverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.