Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617857

FEI Number

3000058367

Entity Name

Spectral Medical Inc.

City/State/Country

TORONTO Ontario, CA

Establishment Address

135 The West Mall, Unit 2, TORONTO Ontario M9C 1C2, CA

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Spectral Medical Inc. (Owner Number: 9034643)

Owner / Operator Contact Address

135 The West Mall, Unit 2, Toronto, CA-ON M9C 1C2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EAA Smart Line TL Luminometer Sirius 2 Tube Luminometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGS	Assay, Endotoxin Activity, Chemiluminescent	Microbiology	Class 2	866.3210	2025-06-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2018-05-30

Official Correspondent

Narvin Ali

US Agent Details

Karin Hughes Business: Beaufort Email: khughes@beaufortcro.com Phone: (757) 3836025

Related Public Records

Same Entity

Spectral Medical Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617857. Last updated year: 2026. Please use registration number 9617857 when referencing this establishment in official correspondence.