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. Device class: 2.
Clearance details
- Applicant
- Orion Diagnostica, OY
- 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
- Oulu, FI
Recent devices under product code DCK
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