K090283
Substantially EquivalentCALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
- Applicant
- Genchem, Inc.
- Product code
- JIX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Brea, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.