Medical Device Manufacturer · CA , Toronto, Ontario

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

12 submissions · 11 cleared · Since 1997

12

Total

11

Cleared

1

Denied

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

10 devices

1-10 of 10

Cleared Mar 19, 2003

SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

Chemistry · 71d

Cleared Sep 30, 2002

SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

Chemistry · 68d

Cleared May 24, 2002

SPECTRAL'S 2 IN 1 (TNI-MYO)

Chemistry · 60d

Cleared Feb 01, 2002

SPECTRAL'S TROPONIN I

Chemistry · 50d

Cleared Oct 04, 1999

CARDIOQUANT TROPONIN I TEST

Chemistry · 103d

Cleared Jun 11, 1999

CARDIOQUANT CARDIAC ASSESSMENT CONTROLS

Chemistry · 46d

Cleared Oct 07, 1998

MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST

Chemistry · 68d

Cleared May 07, 1998

CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)

Chemistry · 13d

Cleared Jul 28, 1997

CARDIAC STATUS CONTROLS/TROPONIN I

Chemistry · 11d

Cleared Jul 25, 1997

CARDIAC STATUS CONTROLS

Chemistry · 29d