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Wallac OY

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
DEN140010PERKINELMER ENLITE NEONATAL TREC TEST SYSTEMDecember 15, 2014
K131284GSP NEONATAL BIOTINIDASE KITNovember 14, 2013
K100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UJuly 23, 2010
K081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITApril 16, 2009
K071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BAugust 7, 2008
K070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112April 14, 2008
K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367March 8, 2006
K050960MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KITJuly 11, 2005
K042425AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITSeptember 30, 2004
K042424DELFIA NEONATAL 17A-OH-PROGESTERONE KITSeptember 30, 2004
K003664DELFIA NEONATAL IRT KIT, MODEL A005-110February 14, 2001
K003668AUTODELFIA NEONATAL IRT KIT, MODEL B005-112February 12, 2001
K993697DELFIA NEONATAL IRT KITJune 9, 2000
DEN990008WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000February 15, 2000
K982307WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000February 2, 1999
K943416DELFIA NEONATAL THYROXINE KITMarch 10, 1995
K944490AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITDecember 9, 1994
K940449DELFIA SHBG KITSeptember 6, 1994
K935047AUTO DELFIAMay 23, 1994
K932951DELFIA TESTTOSTERONE KITAugust 3, 1993