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FDA 510(k)

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

K-Number: K142993 · 2016-03-10

ApplicantOrion Diagnostica, OY
Decision Date2016-03-10
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is a medical device manufactured by Orion Diagnostica, OY. It received FDA 510(k) clearance on 2016-03-10 under approval number K142993. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is a medical device that received FDA 510(k) clearance on 2016-03-10. It is manufactured by Orion Diagnostica, OY. The 510(k) number is K142993.

When was QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument approved by the FDA?

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument received FDA 510(k) clearance on 2016-03-10, under approval number K142993.

What company makes QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is manufactured by Orion Diagnostica, OY.

What is the FDA product code for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?

The FDA product code for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is DCK.

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Related PubMed Literature

PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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