MODIFICATION TO BIOSTAR OIA SHIGATOX— 510(k) K071799
Substantially EquivalentIverness Medical Professional Diagnostics
FDA 510(k) clearance K071799 for MODIFICATION TO BIOSTAR OIA SHIGATOX, Substantially Equivalent on 2007-10-02. Applicant: Iverness Medical Professional Diagnostics.
Clearance details
- Applicant
- Iverness Medical Professional Diagnostics
- Product code
- Code GNA
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, CO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.