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. Device class: 2.
Clearance details
- Applicant
- Celera Diagnostics
- Product code
- Code NUA
- Device class
- Class 2
- Regulation
- 21 CFR 866.5900
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.