QuikRead Go CRP, QuikRead Go CRP Verification Set, QuikRead Go CRP Control Set, And QuikRead Go Instrument

C-reactive Protein, Antigen, Antiserum, And Control

ORION DIAGNOSTICA OY

The following data is part of a premarket notification filed by Orion Diagnostica Oy with the FDA for Quikread Go Crp, Quikread Go Crp Verification Set, Quikread Go Crp Control Set, And Quikread Go Instrument.

Pre-market Notification Details

• Device ID: K142993
• 510k Number: K142993
• Device Name: QuikRead Go CRP, QuikRead Go CRP Verification Set, QuikRead Go CRP Control Set, And QuikRead Go Instrument
• Classification: C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: ORION DIAGNOSTICA OY KIVIHARJUNTIE 11 4B Oulu, FI 90220
• Contact: Anja Kontio
• Correspondent: Anja Kontio; ORION DIAGNOSTICA OY KIVIHARJUNTIE 11 4B Oulu, FI 90220
• Product Code: DCK
• Subsequent Product Code: JJQ
• Subsequent Product Code: JJX
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-10-16
• Decision Date: 2016-03-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06438115000198	K142993	000
06438115000112	K142993	000
06438115000105	K142993	000
06438115000099	K142993	000