Medical Device Manufacturer · CA , Toronto, Ontario

Spectral Diagnostics, Inc. - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 1997

Recent clearances: CARDIAC STATUS CONTROLS/TROPONIN I, CARDIAC STATUS CONTROLS

12

Total

11

Cleared

1

Denied

FDA 510(k) Regulatory Record - Spectral Diagnostics, Inc. Microbiology ✕

2 devices

1-2 of 2

Cleared Nov 30, 2006

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

Microbiology · 442d

Not Cleared Jun 16, 2003

ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

DEN030002 · NGS

Microbiology · 63d