GEM Premier ChemSTAT— 510(k) K183555
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K183555 for GEM Premier ChemSTAT, Substantially Equivalent on 2019-02-16. Applicant: Instrumentation Laboratory CO.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code JFY
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.