GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)— 510(k) K160415
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K160415 for GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation), Substantially Equivalent on 2016-12-14. Applicant: Instrumentation Laboratory CO.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code GKF
- Advisory panel
- Hematology
- 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.