FDA.reportPublic FDA data

Spectral Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96178573000058367Spectral Medical Inc.1N2026-01-01135 The West Mall, Unit 2 TORONTO Ontario CA M9C 1C2

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
179401396612317K183176Endotoxin Activity Assay (EAA)NGS2019-03-12
179401438814709DEN030002ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICENGS2003-06-16
179401200773756

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NGS22019-03-12

PMN#