Spectral Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | November 30, 2006 |
| DEN030002 | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE | June 16, 2003 |
| K030057 | SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST | March 19, 2003 |
| K022409 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | September 30, 2002 |
| K020950 | SPECTRAL'S 2 IN 1 (TNI-MYO) | May 24, 2002 |
| K014105 | SPECTRAL'S TROPONIN I | February 1, 2002 |
| K992127 | CARDIOQUANT TROPONIN I TEST | October 4, 1999 |
| K991447 | CARDIOQUANT CARDIAC ASSESSMENT CONTROLS | June 11, 1999 |
| K982679 | MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST | October 7, 1998 |
| K981474 | CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) | May 7, 1998 |
| K972687 | CARDIAC STATUS CONTROLS/TROPONIN I | July 28, 1997 |
| K972408 | CARDIAC STATUS CONTROLS | July 25, 1997 |