Medical Device Manufacturer · FI , Finland

Wallac OY - FDA 510(k) Cleared Devices

22 submissions · 21 cleared · Since 1992

22

Total

21

Cleared

1

Denied

FDA 510(k) Regulatory Record - Wallac OY Chemistry ✕

18 devices

1-12 of 18

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 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

Cleared Jun 09, 2000

DELFIA NEONATAL IRT KIT

Chemistry · 220d

Cleared Mar 10, 1995

DELFIA NEONATAL THYROXINE KIT

Chemistry · 238d