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FDA 510(k) Applications Submitted by WALLAC OY
FDA 510(k) Number
Submission Date
Device Name
Applicant
K071649
06/18/2007
NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
WALLAC OY
K070889
03/30/2007
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
WALLAC OY
K050960
04/18/2005
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
WALLAC OY
K042424
09/08/2004
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
WALLAC OY
K042425
09/08/2004
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
WALLAC OY
K993697
11/02/1999
DELFIA NEONATAL IRT KIT
WALLAC OY
K003664
11/28/2000
DELFIA NEONATAL IRT KIT, MODEL A005-110
WALLAC OY
K003668
11/28/2000
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
WALLAC OY
K131284
05/06/2013
GSP NEONATAL BIOTINIDASE KIT
WALLAC OY
K081922
07/07/2008
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
WALLAC OY
K100682
03/10/2010
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
WALLAC OY
DEN140010
02/19/2014
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
WALLAC OY
K050709
03/18/2005
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
WALLAC OY
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