Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015499222

FEI Number

3015499222

Entity Name

IKOR SISTEMAS ELECTRONICOS, SL

City/State/Country

San Sebastian Guipuzcoa, ES

Establishment Address

Parque Empresarial Zuatzu s/n, San Sebastian Guipuzcoa 20018, ES

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IKOR Sistemas Electronicos, SL (Owner Number: 10060537)

Owner / Operator Contact Address

Parque Empresarial Zuatzu s/n, San Sebastian, ES-SS 20018, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

microINR® Meter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2021-07-15

Official Correspondent

ESTIBALIZ CASTELRUIZ AGUIRRE

US Agent Details

Stephan Toupin Business: Dawa Medical Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

IKOR Sistemas Electronicos, SL

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.

Similar Registrations

Registration Number	Establishment Name	Location
3007507465	COAGUSENSE INC	Fremont, CA, US
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3008386529	TCOAG IRELAND LIMITED	BRAY Wicklow, IE
1219029	NOVA BIOMEDICAL CORPORATION	WALTHAM, MA, US
2245451	DIAGNOSTICA STAGO, INC.	PARSIPPANY, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015499222. Last updated year: 2026. Please use registration number 3015499222 when referencing this establishment in official correspondence.