Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017875469

FEI Number

3017875469

Entity Name

ZACROS CORPORATION

City/State/Country

Tokyo, JP

Establishment Address

1-1-1 KOISHIKAWA, BUNKYO-KU, BUNKYO GARDEN GATE TOWER 22F, Tokyo 112-0002, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ZACROS CORPORATION (Owner Number: 10062628)

Owner / Operator Contact Address

1-1-1 Koishikawa, Bunkyo-ku, Tokyo, JP-13 112-0002, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191364

PMA Number

N/A

All Registered Proprietary Names

T-TAS 01 Total Thrombus Formation Analysis System Instrument BAPA Tube for T-TAS 01 PL Chip for T-TAS 01 PL Chip Reservoir Set for T-TAS 01 PL Chip Reservoir set PL Chip BAPA tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2020-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Jeffrey Dahlen Business: Hikari Dx, Inc. Email: jeff@hikaridx.com Phone: (619) 7420203

Related Public Records

Same Entity

ZACROS CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016571810	ZACROS CORPORATION MIE FACILITY	NABARI CITY Mie, JP

Similar Registrations

Registration Number	Establishment Name	Location
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US
2518152	CHRONO-LOG CORP.	HAVERTOWN, PA, US
3002721930	Accriva Diagnostics, Inc.	San Diego, CA, US
3005269352	Invetech Pty Ltd	Mount Waverley Victoria, AU
3016571810	ZACROS CORPORATION MIE FACILITY	NABARI CITY Mie, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017875469. Last updated year: 2026. Please use registration number 3017875469 when referencing this establishment in official correspondence.