Medical Device Manufacturer · US , Norton , OH

Wallac, Inc. - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 1999

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - Wallac, Inc. Chemistry ✕

2 devices

1-2 of 2

Not Cleared Feb 15, 2000

WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000

DEN990008 · NAK

Chemistry · 57d

Cleared Feb 02, 1999

WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000

Chemistry · 216d