Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007507465

FEI Number

3007507465

Entity Name

COAGUSENSE INC

City/State/Country

Fremont, CA, US

Establishment Address

48377 Fremont Blvd Ste 113, Fremont, CA 94538, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Coagusense Inc (Owner Number: 10029003)

Owner / Operator Contact Address

48377 Fremont Blvd., ste 113, Fremont, CA 94538, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093243

PMA Number

N/A

All Registered Proprietary Names

Coag-Sense PT/INR Professional 5-Box Promo (06F73-05) Coag-Sense PT/INR Monitoring System Patient Self Testing (03P70-03) Coag-Sense Portable Printer Paper, Bag of 5 Rolls (PD-99906) Coag-Sense PT2 Replacement Carrying Case (03P75-01) Coag-Sense Patient Test Strip Kit (03P56-50) Coag-Sense PT2 Power Supply, Switching Wall Adaptor, 5v/20W (03P74-01) Sample Transfer Tubes, Glass Plastic Clad with Plunger (03P52-54, 03P52-55) Assure PT Care Test Strip Kit, 50 Count Coag-Sense PT2 Portable Printer, USB and Bluetooth (03P76-01) Coag-Sense Patient Test Strip Kit 50 Count (03P56-50) Coag-Sense Patient Test Strip Kit 50 Count (03P57-50) Coag-Sense PT2 PT/INR Patient Self-Testing 1-Box Promo (06F73-06) Coag-Sense PT/INR Professional 3-Box (06F73-03) Coag-Sense PT/INR Test Strip Kit, Drop Ship Only (03P56-50DS) Coag-Sense PT/INR Test Strip Kit, Drop Ship Only (03P57-50DS) Coag-Sense Prothrombin Time (PT) /INR Patient Self-Test System (03P70-01) Coag-Sense Control Test Strip Kit - 10 (03P69-10) Coag-Sense PT2 Stylus Pen (03P77-01) Sample Transfer Tubes, Glass Plastic Clad with Plunger (03P52-57, 03P52-55) Tera Barcode Scanner with Charging Cradle (03P78-03) Coag-Sense Prothrombin Time PT/INR Professional System (03P70-02) Coag-Sense Prothrombin Time PT/INR Professional System (04P70-02) Coag-Sense PT2 PT/INR Professional 1-Box Promo (06F73-07) Assure PT Care PT/INR Monitoring System Lancets Auto Single Use, 21Ga, 2.2mm depth, sterile (03P58-04) Coag-Sense PT2 Wireless Barcode Scanner (03P78-01) Coag-Sense PT/INR 6 Test Strip Kit w/ Transfer Tube (03P70-06) Coag-Sense PT2 PT/INR Professional 3-Box Promo (06F74-03) Coag-Sense PT2 PT/INR Professional 1-Box Promo (06F74-01) Coag-Sense PT2 PT/INR Professional 5-Box Promo (06F74-05) CoaguSense Prothrombin Time (PT)/INR Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2019-03-29
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2010-11-10

Official Correspondent

Mike Acosta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Coagusense Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020679	Hemosense, Inc.	INRATIO	2002-05-06
K070005	Instrumentation Laboratory CO	HEMOSIL RECOMBIPLASTIN 2G	2007-08-15
K931117	Instrumentation Laboratory CO	ASSESS(TM) LOW ABNORMAL CONTROL	1994-03-30
K933252	Instrumentation Laboratory CO	IL TEST (TM) PT-FIBRINOGEN HS PLUS	1993-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0077-2019	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Z-0832-2015	Instrumentation Laboratory Co.	2	HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Z-0895-2018	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Z-1246-06	Instrumentation Laboratory Co.	2	HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
Z-1247-06	Instrumentation Laboratory Co.	2	Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007507465. Last updated year: 2026. Please use registration number 3007507465 when referencing this establishment in official correspondence.