Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006850222

FEI Number

3006850222

Entity Name

SEKISUI MEDICAL CO., LTD. Tokuyama Plant

City/State/Country

Shunan-City Yamaguchi, JP

Establishment Address

4560,Kaisei-cho, Shunan-City Yamaguchi 746-0006, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SEKISUI MEDICAL CO., LTD. (Owner Number: 10023817)

Owner / Operator Contact Address

1-3, Nihonbashi 2-chome, Chuo-ku, Tokoyo, JP-13 103-0027, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BD Vacutainer Rapid Serum Tube (RST BD Vacutainer(R) COLUMN UNIT 80; ELUENT 80A; ELUENT 80B; ELUENT 80CV; Hemolysis Washing Solution 80H; Control Dilution Set 80

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2010-08-16
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2009-09-14
LDM	Instrumentation, High Pressure Liquid Chromatography	Clinical Chemistry	Class 1	862.2260	2026-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

Jason Bilobram Business: Sekisui Diagnostics, LLC Email: jason.bilobram@sekisuidiagnostics.com Phone: (781) 6527848

Related Public Records

Same Entity

SEKISUI MEDICAL CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003539867	SEKISUI MEDICAL CO., LTD. Tsukuba Plant	Ryugasaki-shi Ibaraki, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006850222. Last updated year: 2026. Please use registration number 3006850222 when referencing this establishment in official correspondence.