QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
K-Number: K142993 · 2016-03-10
Device Summary
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. The listed applicant is Orion Diagnostica, OY. The 510(k) number is K142993.
When did QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument receive FDA 510(k) clearance?
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 510(k) number K142993.
Who is the listed applicant for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?
The FDA 510(k) record lists Orion Diagnostica, OY as the applicant. This does not by itself establish the device manufacturer.
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.
Related Devices (Code: DCK)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.