XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267— 510(k) K083846
Substantially EquivalentLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance K083846 for XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267, Substantially Equivalent on 2009-09-01. Applicant: Luminex Molecular Diagnostics, Inc..
Clearance details
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Product code
- Code NUA
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, Ontario, CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.