GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator— 510(k) K160225
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K160225 for GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator, Substantially Equivalent on 2016-12-14. Applicant: Instrumentation Laboratory CO.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code JGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, 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.