Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5— 510(k) K160729
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K160729 for Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5, Substantially Equivalent on 2016-06-13. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code PMT
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.