Sdi Diagnostics Inc

FDA Filings

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

FDA Registration(s)

Registration Number	1220253
FEI Number	1220253
Name	SDI DIAGNOSTICS, INC.
Owner & Operator	SDI DIAGNOSTICS, INC
Contact Address	10 HAMPDEN DR. -- South Easton MA 02375 US
Official Correspondent	MICHAEL J BOYLE x-508-2387033-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	10 Hampden Dr South Easton, MA 02375 US
Establishment Type	Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K150515 \| BZG SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	IQSense Spirometer Mouthpiece	2016-09-09
PMN K150515 SDI DIAGNOSTICS, INC.	IQSense Flow Sensor Mouthpiece	2016-01-12
BYP SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	Safe-t-chek mouthpiece	2014-02-07
BYP SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	Oval Plastic Disposable Mouthpiece	2014-02-07
BYP SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	ACCURETTE	2014-02-07
PMN K983909 \| BZG SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	Spirobank	2012-04-13
PMN K934509 \| CAH SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	Pulmoguard	2012-04-13
PMN K062913 \| BZG SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	AstraGuard Bacterial/Viral filter	2012-04-13
PMN K061571 \| BZG SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	AstraTouch Diagnostic Spirometer	2012-04-13
PMN K061571 \| BZG SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	Astra300 Diagnostic spirometer	2012-04-13
PMN K092813 SDI DIAGNOSTICS, INC.	ASTRASONIC SPIROMETER, MODEL 29-8000	2010-07-16
PMN K061571 SDI DIAGNOSTICS, INC.	ASTRA 300	2007-01-31
PMN K062913 SDI DIAGNOSTICS, INC.	ASTRAGUARD PULMONARY FUNCTION FILTER	2007-01-26
PMN K033939 \| BZG SDI DIAGNOSTICS, INC. [SDI DIAGNOSTICS, INC]	FLOSENSE II	2006-12-05
PMN K033939 SDI DIAGNOSTICS, INC.	FLOSENSE II, MODEL 29-8040	2004-01-30
PMN K031643 SDI DIAGNOSTICS, INC.	SPIROTEL, MODEL 29-1020	2003-12-09
PMN K990962 SDI DIAGNOSTICS, INC.	FLOSENSE, MODEL 29-8010	2000-01-07
PMN K934509 SDI DIAGNOSTICS, INC.	PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER	1993-10-21

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020072847148	Barcelona ,Spain -> New York/Newark Area, Newark, New Jersey	SPIROMETERS	13 PKG
20200622627	Ningpo ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	NOSE CLIP	25 CTN
202006087463	Ningpo ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	NOSE CLIP	25 CTN
2020010311837	Ningpo ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MOUTHPIECE NOSE CLIP	359 CTN