K940209
Substantially EquivalentORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- GGN
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.