SPECTROCHIP GLOBAL INC.

FDA Device Registration & Listing · Burlington Ontario, CA · Registration 3043624347

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043624347
FEI Number
3043624347
Entity Name
SPECTROCHIP GLOBAL INC.
City/State/Country
Burlington Ontario, CA
Establishment Address
921 Gateway Dr, Burlington Ontario L7L 5J7, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SpectroChip Global Inc. (Owner Number: 10095111)
Owner / Operator Contact Address
921 Gateway Dr, Burlington, CA-ON L7L 5J7, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PrecisionCare

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2026-01-26

Official Correspondent

Edward Wallace

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

SpectroChip Global Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K760232 Instrumentation Laboratory CO PRINTER, IL 460 1976-08-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043624347. Last updated year: 2026. Please use registration number 3043624347 when referencing this establishment in official correspondence.
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