QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument— 510(k) K142993
Substantially EquivalentOrion Diagnostica, OY
FDA 510(k) clearance K142993 for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument, Substantially Equivalent on 2016-03-10. Applicant: Orion Diagnostica, OY.
Clearance details
- Applicant
- Orion Diagnostica, OY
- Product code
- Code DCK
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oulu, FI
Data sourced from openFDA. This site is unofficial and independent of the FDA.