Medical Device Manufacturer · CA , Toronto, Ontario

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

12 submissions · 11 cleared · Since 1997

Total

Cleared

Denied

Spectral Diagnostics, Inc. has 11 FDA 510(k) cleared chemistry devices. Based in Toronto, Ontario, CA.

Historical record: 11 cleared submissions from 1997 to 2006.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

12 devices

1-12 of 12

Cleared Nov 30, 2006

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

K052519 · NOP

Microbiology · 442d

Not Cleared Jun 16, 2003

ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

DEN030002 · NGS

Microbiology · 63d

Cleared Mar 19, 2003

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

K030057 · MMI

Chemistry · 71d

Cleared Sep 30, 2002

SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

K022409 · JHT

Chemistry · 68d

Cleared May 24, 2002

SPECTRAL'S 2 IN 1 (TNI-MYO)

K020950 · MMI

Chemistry · 60d

Cleared Feb 01, 2002

SPECTRAL'S TROPONIN I

K014105 · MMI

Chemistry · 50d

Cleared Oct 04, 1999

CARDIOQUANT TROPONIN I TEST

K992127 · MMI

Chemistry · 103d

Cleared Jun 11, 1999

CARDIOQUANT CARDIAC ASSESSMENT CONTROLS

K991447 · JJY

Chemistry · 46d

Cleared Oct 07, 1998

MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST

K982679 · DDR

Chemistry · 68d

Cleared May 07, 1998

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

K981474 · JJY

Chemistry · 13d

Cleared Jul 28, 1997

CARDIAC STATUS CONTROLS/TROPONIN I

K972687 · JJX

Chemistry · 11d

Cleared Jul 25, 1997

CARDIAC STATUS CONTROLS

K972408 · JJT

Chemistry · 29d

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

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