MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER— 510(k) K864872
Substantially EquivalentMedica Corp.
FDA 510(k) clearance K864872 for MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER, Substantially Equivalent on 1987-03-13. Applicant: Medica Corp..
Clearance details
- Applicant
- Medica Corp.
- 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.