Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012240236

FEI Number

3012240236

Entity Name

SHINO-TEST CORPORATION

City/State/Country

Sagamihara Kanagawa, JP

Establishment Address

4-1-93 Oonodai, Minami-ku, Sagamihara Kanagawa 252-0331, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHINO-TEST CORPORATION (Owner Number: 10092089)

Owner / Operator Contact Address

3-7-9 Kanda-Surugadai, Chiyoda-ku, JP-13 101-8410, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LIP Control LIP Control (H) Cygnus Auto LIP LIP Serum Calibrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-03
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2024-12-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2024-12-03

Official Correspondent

Isoko Hirase

US Agent Details

Isoko Hirase Business: Medical Device Compliance Support LLC Email: hirase@mdcsjapan.com Phone: (469) 3631224

Related Public Records

Same Entity

SHINO-TEST CORPORATION

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
K882795	Baxter Healthcare Corp	DADE(R) CK-MB IMMUNOASSAY CONTROL	1988-08-29
K971777	Instrumentation Laboratory CO	QUANTEX ASO-CRP-RF CONTROL	1997-05-27
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021	Siemens Healthcare Diagnostics, Inc.	2	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

Similar Registrations

Registration Number	Establishment Name	Location
3050015	ASTORIA-PACIFIC, INC.	Clackamas, OR, US
3005333358	ABBOTT LABORATORIES	Lake Forest, IL, US
2085085	MORE DIAGNOSTICS INC.	Los Osos, CA, US
2085064	CLINIQA CORPORATION	San Marcos, CA, US
2032900	Diazyme Laboratories, Inc.	POWAY, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012240236. Last updated year: 2026. Please use registration number 3012240236 when referencing this establishment in official correspondence.