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Wallac OY

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K131284 GSP NEONATAL BIOTINIDASE KITNAK2013-11-14 View
510(k) K100682 GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UJLX2010-07-23 View
510(k) K081922 AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITJLX2009-04-16 View
510(k) K071649 NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BJIA2008-08-07 View
510(k) K070889 AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112CGZ2008-04-14 View
510(k) K050709 RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367GKA2006-03-08 View
510(k) K050960 MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KITJLX2005-07-11 View
510(k) K042425 AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITJLX2004-09-30 View
510(k) K042424 DELFIA NEONATAL 17A-OH-PROGESTERONE KITJLX2004-09-30 View
510(k) K003664 DELFIA NEONATAL IRT KIT, MODEL A005-110CGZ2001-02-14 View
510(k) K003668 AUTODELFIA NEONATAL IRT KIT, MODEL B005-112CGZ2001-02-12 View
510(k) K993697 DELFIA NEONATAL IRT KITCGZ2000-06-09 View
510(k) K943416 DELFIA NEONATAL THYROXINE KITCDX1995-03-10 View
510(k) K944490 AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITCGI1994-12-09 View
510(k) K940449 DELFIA SHBG KITCDZ1994-09-06 View
510(k) K935047 AUTO DELFIAKHO1994-05-23 View
510(k) K932951 DELFIA TESTTOSTERONE KITCDZ1993-08-03 View
510(k) K930732 DELFIA CORTISOL KITJFT1993-07-27 View
510(k) K930484 DELFIA(R) HGH KITCFL1993-05-11 View
510(k) K924594 DELFIA DIGOXIN KITKXT1992-12-17 View
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