Orion Diagnostica, OY is one of 27 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.
Orion Diagnostica, OY - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
Orion Diagnostica, OY has 4 FDA 510(k) cleared medical devices. Based in Espoo, FI.
Historical record: 4 cleared submissions from 2004 to 2016. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Orion Diagnostica, OY Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Orion Diagnostica, OY
4 devices
Cleared
Mar 10, 2016
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control...
Immunology
511d
Cleared
May 04, 2005
ORION DIAGNOSTICA UNIQ PINP RIA
Chemistry
173d
Cleared
Nov 18, 2004
QUIKREAD CRP CALIBRATOR SET
Chemistry
52d
Cleared
Sep 24, 2004
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085
Chemistry
15d