Optimum Imaging Diagnostics

FDA Filings

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

FDA Registration(s)
Registration Number3011875106
FEI Number3011875106
NameOPTIMUM IMAGING DIAGNOSTICS, LLC
Owner & OperatorOptimum Imaging Diagnostics
Contact AddressSuite 1 6 Science Park Road
Scarborough ME 04074 US
Official Correspondent
  • Paul E Hamm
  • x-207-2170659-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6 SCIENCE PARK RD STE 1
Scarborough, ME 04074 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
HEA-820-10010 Synthetic Urine Negative Control2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
GPR-950-10223 Color Developer2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
GPR-950-10222 Stop Solution2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
GPR-950-10221 Wash Buffer2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
HEA-820-10076 Mid Positive Control2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
GLM-950-10045 Positive Stock Standard2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
HSR-920-10044 Anti-Histoplasma Conjugate2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
HSR-910-10043 - Anti-Histoplasma Coated Microwells2018-10-03

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