K993104
Substantially EquivalentSTAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
- Applicant
- Nova Biomedical Corp.
- Product code
- GLY
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.