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FDA 510(k) Applications Submitted by ORION DIAGNOSTICA OY
FDA 510(k) Number
Submission Date
Device Name
Applicant
K142993
10/16/2014
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
ORION DIAGNOSTICA OY
K042625
09/27/2004
QUIKREAD CRP CALIBRATOR SET
ORION DIAGNOSTICA OY
K042442
09/09/2004
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
ORION DIAGNOSTICA OY
K043125
11/12/2004
ORION DIAGNOSTICA UNIQ PINP RIA
ORION DIAGNOSTICA OY
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