ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8— 510(k) K090901
Substantially EquivalentOsmetech Molecular Diagnostics
FDA 510(k) clearance K090901 for ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8, Substantially Equivalent on 2009-07-06. Applicant: Osmetech Molecular Diagnostics.
Clearance details
- Applicant
- Osmetech Molecular Diagnostics
- Product code
- Code NUA
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pasadena, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.