VITROS Chemistry Products hsCRP Reagent— 510(k) K160712
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K160712 for VITROS Chemistry Products hsCRP Reagent, Substantially Equivalent on 2017-07-14. Applicant: Ortho Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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