FDA.reportPublic FDA data

COAGUSENSE INC

Matched from indexed company URL: Coagusense-Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30075074653007507465COAGUSENSE INC1N2026-01-0148377 Fremont Blvd Ste 113 Fremont CA US 94538

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860007370809Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing - The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing isan in vitro diagnostic device that provides quantitative prothrombin time (PT) results,expressed in INR units. It uses fresh capillary whole blood.The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing isintended for use by properly selected and suitably trained patients or their caregivers on theorder of the treating physician to monitor patients who are on anticoagulation therapy. Patientsshould be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing.The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is notintended to be used for screening purposes.The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Self-Testing is intendedto be used by a single person and should not be shared.(510) 270-5442macosta@coagusense.com
00860007370861Coag-sense - Coag-Sense PT/INR Professional 3-Box Promo1-866-903-0890support@coagusense.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1017731467525550K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS2022-10-05
1017731113045674K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS2019-02-21
1017731684087297K101145SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250FMK2010-10-21
1017731960605592K093243COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEMGJS2010-04-07
1017731221676945K050243IMMEDIA PROTHROMBIN TIME SYSTEMJPA2005-06-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GJS32022-10-05
FMK12010-10-21
JPA12005-06-06

GUDID#

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing - The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing isan in vitro diagnostic device that provides quantitative prothrombin time (PT) results,expressed in INR units. It uses fresh capillary whole blood.The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing isintended for use by properly selected and suitably trained patients or their caregivers on theorder of the treating physician to monitor patients who are on anticoagulation therapy. Patientsshould be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing.The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is notintended to be used for screening purposes.The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Self-Testing is intendedto be used by a single person and should not be shared.

COAGUSENSE INC.

2026-05-12