Spectral Diagnostics, Inc.
Medical device manufacturer in Toronto, Ontario, CA.
11510(k) clearances
0PMA approvals
0recalls
Device types
- MMI Immunoassay Method, Troponin Subunit 4
- JJY Multi-Analyte Controls, All Kinds (Assayed) 2
- JJT Enzyme Controls (Assayed And Unassayed) 1
- JJX Single (Specified) Analyte Controls… 1
- DDR Myoglobin, Antigen, Antiserum, Control 1
- JHT Chromatographic Separation, Cpk Isoenzymes 1
- NOP Elisa, Antibody, West Nile Virus 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K052519 | Spectral West Nile Virus Igm Status TestNOP · Traditional | 11/30/2006SE |
| K030057 | Spectral Cardiac Status Ck-Mb/Myoglobin/Troponin I 3-IN-1 TestMMI · Traditional | 03/19/2003SE |
| K022409 | Spectral's Cardiac Status Ck-Mb Rapid TestJHT · Traditional | 09/30/2002SE |
| K020950 | Spectral's 2 in 1 (Tni-Myo)MMI · Traditional | 05/24/2002SE |
| K014105 | Spectral's Troponin IMMI · Traditional | 02/01/2002SE |
| K992127 | Cardioquant Troponin I TestMMI · Traditional | 10/04/1999SE |
| K991447 | Cardioquant Cardiac Assessment ControlsJJY · Traditional | 06/11/1999SE |
| K982679 | Multiquant (R) Quantitative Myoglobin TestDDR · Traditional | 10/07/1998SE |
| K981474 | Cardiac Status Controls (Ck-Mb/Myoglobin/Troponin I)JJY · Traditional | 05/07/1998SE |
| K972687 | Cardiac Status Controls/Troponin IJJX · Traditional | 07/28/1997SE |
| K972408 | Cardiac Status ControlsJJT · Traditional | 07/25/1997SE |