Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2084025

FEI Number

2084025

Entity Name

KAMIYA BIOMEDICAL COMPANY LLC

City/State/Country

Tukwila, WA, US

Establishment Address

12779 Gateway Dr S, Tukwila, WA 98168, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KAMIYA BIOMEDICAL COMPANY LLC (Owner Number: 9001370)

Owner / Operator Contact Address

12779 GATEWAY DRIVE S, Tukwila, WA 98168, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993606

PMA Number

N/A

All Registered Proprietary Names

K-ASSAY(R) IgG K-ASSAY(R) Cystatin C K-ASSAY(R) Cystatin C Control K-ASSAY(R) Cystatin C Calibrator K-ASSAY(R) Apo AI K-ASSAY(R) Fibrinogen Calibrator K-ASSAY(R) Fibrinogen K-ASSAY(R) ASO/RF/CRP Control K-ASSAY(R) Lp(a) Calibrator K-ASSAY(R) Lp(a) K-ASSAY(R) Ferritin K-ASSAY(R) Ferritin Calibrator K-ASSAY(R) Alpha-1 Microglobulin K-ASSAY(R) Serum/Plasma A1-MG Calibrator K-ASSAY(R) Urine A1-MG Calibrator K-ASSAY(R) RF (Ver.2) K-ASSAY(R) RF Calibrator (Ver.2) K-ASSAY(R) CRP K-ASSAY(R) Insulin K-ASSAY(R) Insulin Calibrator K-ASSAY(R) Liquid ITA Control K-ASSAY(R) Lp(a) Control K-ASSAY(R) IgA K-ASSAY Microalbumin Calibrator K-ASSAY Microalbumin K-ASSAY(R) Alpha-1 AG K-ASSAY(R) Multi-Analyte Calibrator K-ASSAY(R) CRP(3) Calibrator E K-ASSAY(R) CRP(3) Calibrator F K-ASSAY(R) CRP(3) Calibrator D K-ASSAY(R) CRP(3) K-ASSAY (R) D-Dimer Control K-ASSAY CRP (VER.2) K-ASSAY(R) Transferrin K-ASSAY(R) CRP Calibrator K-ASSAY(R) Apo AI/B Calibrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-11-13
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2010-10-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-10-12
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2010-10-12
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Immunology	Class 2	866.5580	2007-11-13
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2007-11-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-11-13
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-11-13
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2007-11-13
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-11-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2020-12-22
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2007-11-13
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-13
MGA	Alpha-1 Microglobulin, Antigen, Antiserum, Control	Immunology	Class 1	866.5400	2005-09-01
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2020-10-22
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2020-10-22
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-11-13
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-11-13
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2006-04-03
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-11-13
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2007-11-13
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2007-11-13
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2010-05-04
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2010-05-04
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2007-11-13
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-13
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2019-04-04
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-11-13
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2018-05-23
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2025-05-28
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2014-03-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-03-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-03-07
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2007-11-13
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-11-13
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-12-17
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2007-11-13
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-13

Official Correspondent

COLIN GETTY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KAMIYA BIOMEDICAL COMPANY LLC

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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
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

Similar Registrations

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3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
3000148879	HORIBA ABX SAS	MONTPELLIER Herault, FR
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2084025. Last updated year: 2026. Please use registration number 2084025 when referencing this establishment in official correspondence.