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. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code PMT
- Device class
- Class 2
- Regulation
- 21 CFR 866.3215
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.