K961807
Substantially EquivalentCERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- GLK
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.