# Spectral Diagnostics, Inc.

- Location (FDA's records): Toronto, Ontario, CA
- FDA decisions: 12 (1997–2006): 11 510(k) clearances and 1 De Novo grant
- Product codes: MMI (4), JJY (2), JJX (1), JHT (1), NGS (1), DDR (1), JJT (1), NOP (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Focus Technologies, Inc.: 1 (https://510kreport.com/company/focus-technologies)

## Firms that cite its devices most
- Brahms Aktiengesellschaft: 1 (https://510kreport.com/company/brahms-aktiengesellschaft)
- Nano-Ditech Corporation: 1 (https://510kreport.com/company/nano-ditech)

## Its most-cited devices
- DEN030002: Endotoxin Activity Assay (Eaa) Device (2003), cited by 1
- K030057: Spectral Cardiac Status CK-MB/Myoglobin/Troponin I 3-in-1 Test (2003), cited by 1

## Recent decisions
- K052519: Spectral West Nile Virus Igm Status Test (Nov 30, 2006)
- DEN030002: Endotoxin Activity Assay (Eaa) Device (Jun 16, 2003)
- K030057: Spectral Cardiac Status CK-MB/Myoglobin/Troponin I 3-in-1 Test (Mar 19, 2003)
- K022409: Spectral's Cardiac Status CK-MB Rapid Test (Sep 30, 2002)
- K020950: Spectral's 2 in 1 (Tni-Myo) (May 24, 2002)
- K014105: Spectral's Troponin I (Feb 1, 2002)
- K992127: Cardioquant Troponin I Test (Oct 4, 1999)
- K991447: Cardioquant Cardiac Assessment Controls (Jun 11, 1999)

Source page: https://510kreport.com/company/spectral-diagnostics