QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
FDA 510(k) clearance K142993 · decided 2016-03-10
Clearance details
- K-number
- K142993
- Device name
- QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
- Applicant
- Orion Diagnostica, OY
- Decision
- Substantially Equivalent
- Date received
- 2014-10-16
- Decision date
- 2016-03-10
- Days to decision
- 511 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Oulu, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.