Wallac OY - FDA 510(k) Cleared Devices
22
Total
21
Cleared
1
Denied
Wallac OY has 21 FDA 510(k) cleared chemistry devices. Based in Finland, FI.
Historical record: 21 cleared submissions from 1992 to 2013.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
22 devices
Not Cleared
Dec 15, 2014
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
Pathology
299d
Cleared
Nov 14, 2013
GSP NEONATAL BIOTINIDASE KIT
Chemistry
192d
Cleared
Jul 23, 2010
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
Chemistry
135d
Cleared
Apr 16, 2009
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
Chemistry
283d
Cleared
Aug 07, 2008
NEONATAL TOTAL GALACTOSE KIT
Chemistry
416d
Cleared
Apr 14, 2008
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
Chemistry
381d
Cleared
Mar 08, 2006
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400,...
Hematology
355d
Cleared
Jul 11, 2005
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
Chemistry
84d
Cleared
Sep 30, 2004
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
Chemistry
22d
Cleared
Sep 30, 2004
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
Chemistry
22d
Cleared
Feb 14, 2001
DELFIA NEONATAL IRT KIT, MODEL A005-110
Chemistry
78d
Cleared
Feb 12, 2001
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
Chemistry
76d