GEM Premier 5000— 510(k) K203790
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K203790 for GEM Premier 5000, Substantially Equivalent on 2021-08-20. Applicant: Instrumentation Laboratory CO.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code CHL
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
Adverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
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.