Spectral Medical Inc

FDA Filings

This page includes the latest FDA filings for Spectral Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

CANADATORONTO STOCK EXCHANGEEDTDUNS 248909939
FDA Registration(s)
Registration Number9617857
FEI Number3000058367
NameKazem Kazempour
Owner & OperatorSpectral Medical Inc.
Contact Address135 The West Mall, Unit 2
Toronto CA-ON Ontario M9C 1C2 CA
US Agent
Importing Logistics Registration
ImporterSpectral Diagnostics (US), Inc.
Address20201 Century Boulevard Ste 450
Germantown, MD 20874 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address20201 Century Blvd
Germantown, MD 20874 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Spectral Medical Inc
Endotoxin Activity Assay (EAA) EAAST-202021-02-26
Spectral Medical Inc
Smart Line TL Tube Luminometer 840072019-12-23
Spectral Medical Inc
SAMI RRT SM-100-0032019-11-26
Spectral Medical Inc
SAMI RRT Cassette SA-400-002019-11-26
Spectral Medical Inc
SAMI Hemofiltration Cassette SM-200-0032019-11-25
Spectral Medical Inc
SAMI RRT Cassette SA-400-002019-11-22
Spectral Medical Inc
Cassette Hemofiltration SM-200-0032019-06-07
Spectral Medical Inc
Cassette CRRT SM-200-0012019-06-07
Spectral Medical Inc
SAMI CRRT Unit SM-100-0032019-03-15
Spectral Medical Inc
Endotoxin Activity Assay (EAA) EAAST-NA2019-03-15
Spectral Medical Inc.
Endotoxin Activity Assay (EAA)2019-03-12
Kazem Kazempour [Spectral Medical Inc.]
Smart Line TL Luminometer2018-05-30
Spectral Medical Inc.
SAM CRRT Unit, SAM Cassette CRRT2017-12-13
Kazem Kazempour [Spectral Medical Inc.]
EAA2008-02-05

Related Finance Registrations

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.