Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016571810

FEI Number

3016571810

Entity Name

ZACROS CORPORATION MIE FACILITY

City/State/Country

NABARI CITY Mie, JP

Establishment Address

3889-1 TAKINOHARA, NABARI CITY Mie 518-0411, JP

Establishment Type(s)

Manufacture Medical 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
3017875469	ZACROS CORPORATION	Tokyo, JP

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016571810. Last updated year: 2026. Please use registration number 3016571810 when referencing this establishment in official correspondence.