Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Spectral Diagnostics with 11 510(k) clearances. The most recent is a 510(k) clearance dated Nov 30, 2006: SPECTRAL WEST NILE VIRUS IGM STATUS TEST.
| Nov 30, 2006 | SPECTRAL WEST NILE VIRUS IGM STATUS TESTK052519 · NOP | 510(k) clearances |
| Jun 16, 2003 | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICEDEN030002 · NGS | 510(k) clearances |
| Mar 19, 2003 | SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TESTK030057 · MMI | 510(k) clearances |
| Sep 30, 2002 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTK022409 · JHT | 510(k) clearances |
| May 24, 2002 | SPECTRAL'S 2 IN 1 (TNI-MYO)K020950 · MMI | 510(k) clearances |
| Feb 1, 2002 | SPECTRAL'S TROPONIN IK014105 · MMI | 510(k) clearances |
| Oct 4, 1999 | CARDIOQUANT TROPONIN I TESTK992127 · MMI | 510(k) clearances |
| Jun 11, 1999 | CARDIOQUANT CARDIAC ASSESSMENT CONTROLSK991447 · JJY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
