VITROS BRAHMS PCT Reagent Pack and Calibrators— 510(k) K200236
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K200236 for VITROS BRAHMS PCT Reagent Pack and Calibrators, Substantially Equivalent on 2020-02-25. Applicant: Ortho Clinical Diagnostics.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code PMT
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.