Kazem Kazempour

FDA Filings

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

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



Registration Number3013296716
FEI Number3013296716
NameKazem Kazempour
Owner & OperatorPanion & BF Biotech Inc
Contact Address6F.-3, No.306, Sec. 1, Datong Rd., Xizhi
New Taipei City TW-NOTA 221 TW
Official Correspondent
  • Huang Chun-Hao
  • 886-2-6919895-26
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address20201 Century Boulevard 4th Floor
Germantown, MD 20874 US
Establishment TypeForeign Private Label Distributor



FDA Filings

Device
Company
DeviceDate
Kazem Kazempour [Panion & BF Biotech Inc]
Vstrip2019-05-27
Kazem Kazempour [Panion & BF Biotech Inc]
Vstrip2019-05-27
Kazem Kazempour [Panion & BF Biotech Inc]
Vstrip2019-05-27
Kazem Kazempour [Panion & BF Biotech Inc]
Vstrip2019-05-27
Kazem Kazempour [Panion & BF Biotech Inc]
Vstrip2019-05-06
Kazem Kazempour [Spectral Medical Inc.]
Smart Line TL Luminometer2018-05-30
Kazem Kazempour [Spectral Medical Inc.]
EAA2008-02-05

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