Commonwealth Diagnostics I N T Inc

FDA Filings

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

FDA Registration(s)
Registration Number3009236726
FEI Number3009236726
NameCOMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Owner & OperatorCommonwealth Diagnostics International, Inc.
Contact Address39 Norman Street
Salem UY-NOTA 01970 US
Official Correspondent
  • Alexander J Capano
  • 1-888-2565966-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address39 Norman Street
Salem, MA 01970 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
IBSchek IVD-1-Chek2018-06-18
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
IBSchek Blood Collection Kit2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen and Methane Breath Test Collection Kit: Sucrose 6-Tube2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen and Methane Breath Test Collection Kit: SIBO 6-Tube (Lactulose)2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen and Methane Breath Test Collection Kit: SIBO 10-Tube (Lactulose)2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen and Methane Breath Test Collection Kit: SIBO 10-Tube (Glucose)2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen and Methane Breath Test Collection Kit: Lactose 6-Tube2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen and Methane Breath Test Collection Kit: Fructose 6-Tube2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen Breath Test Collection Kit: Sucrose 6-Tube2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen Breath Test Collection Kit: SIBO 10-Tube (Glucose)2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen Breath Test Collection Kit: Lactose 6-Tube2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen Breath Test Collection Kit: Fructose 6-Tube2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen Breath Test Collection Kit: Domestic SIBO 6-Tube (Lactulose)2018-05-09
COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
Hydrogen Breath Test Collection Kit: Domestic SIBO 10-Tube (Lactulose)2018-05-09

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