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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