NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG— 510(k) K093383
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K093383 for NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG, Substantially Equivalent on 2010-07-06. Applicant: bioMerieux, Inc..
Clearance details
- Applicant
- bioMerieux, Inc.
- Product code
- Code OOI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Adverse events under product code OOI
product code OOI- Malfunction
- 2,506
- Other
- 3
- Total
- 2,509
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.