CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01— 510(k) K062028
Substantially EquivalentCelera Diagnostics
FDA 510(k) clearance K062028 for CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01, Substantially Equivalent on 2007-09-07. Applicant: Celera Diagnostics.
Clearance details
- Applicant
- Celera Diagnostics
- Product code
- Code NUA
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.