SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK— 510(k) K141458
Substantially EquivalentFocus Diagnostics
FDA 510(k) clearance K141458 for SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK, Substantially Equivalent on 2014-07-01. Applicant: Focus Diagnostics.
Clearance details
- Applicant
- Focus Diagnostics
- Product code
- Code PGH
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cypress, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.