Company ยท CA
Spectral Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2006. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| NGS | Assay, Endotoxin Activity, Chemiluminescent | 1 |
| NOP | Elisa, Antibody, West Nile Virus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 30, 2006 | K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST Spectral Diagnostics, Inc., CA | NOP |
| Jun 16, 2003 | DEN030002 | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE Spectral Diagnostics, Inc. | NGS |
| Mar 19, 2003 | K030057 | SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST Spectral Diagnostics, Inc., CA | MMI |
| Sep 30, 2002 | K022409 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST Spectral Diagnostics, Inc., CA | JHT |
| May 24, 2002 | K020950 | SPECTRAL'S 2 IN 1 (TNI-MYO) Spectral Diagnostics, Inc., CA | MMI |
| Feb 1, 2002 | K014105 | SPECTRAL'S TROPONIN I Spectral Diagnostics, Inc., CA | MMI |
| Oct 4, 1999 | K992127 | CARDIOQUANT TROPONIN I TEST Spectral Diagnostics, Inc. | MMI |
| Jun 11, 1999 | K991447 | CARDIOQUANT CARDIAC ASSESSMENT CONTROLS Spectral Diagnostics, Inc., CA | JJY |
| Oct 7, 1998 | K982679 | MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST Spectral Diagnostics, Inc., CA | DDR |
| May 7, 1998 | K981474 | CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) Spectral Diagnostics, Inc., CA | JJY |
| Jul 28, 1997 | K972687 | CARDIAC STATUS CONTROLS/TROPONIN I Spectral Diagnostics, Inc., CA | JJX |
| Jul 25, 1997 | K972408 | CARDIAC STATUS CONTROLS Spectral Diagnostics, Inc., CA | JJT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||