FDA.reportPublic FDA data

SDI DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12202531220253SDI DIAGNOSTICS, INC.1N2026-01-0110 Hampden Dr South Easton MA US 02375

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
302781577674484K983909MIR SPIROBANK SPIROMETERBZG1998-12-21
302781464078733K934509PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTERCAH1993-10-21
302781384608080K150515IQSense Flow Sensor MouthpieceBZG2016-01-12
302781505330096K062913ASTRAGUARD PULMONARY FUNCTION FILTERBZG2007-01-26
302781222016691K061571ASTRA 300BZG2007-01-31
302781797081932K033939FLOSENSE II, MODEL 29-8040BZG2004-01-30
302781333164628

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZG52016-01-12
CAH11993-10-21

PMN#