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Kamiya Biomedical Company LLC: FDA-registered device maker in Tukwila, WA, United States, 31 510(k) clearances

Name: Kamiya Biomedical Company LLC FDA registration, clearances, approvals and recalls
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Kamiya Biomedical Company LLC is registered with the FDA (registration 2084025) in Tukwila, WA, United States. It lists 33 device types. The FDA files 31 510(k) clearances under its listings, the newest dated April 18, 2025. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2084025
Address: 12779 Gateway Dr S, Tukwila, WA, United States, 98168
Owner or operator: KAMIYA BIOMEDICAL COMPANY LLC (9001370)
Roles: Manufacturer, Repackager or relabeler
First device listed: July 25, 1997
Registered through: 2026
Brand names listed: K-ASSAY (R) D-Dimer Control, K-ASSAY (R) Factor XIII Reagent, Calibrator, Control, K-ASSAY CRP (VER.2), K-ASSAY Microalbumin, K-ASSAY Microalbumin Calibrator, K-ASSAY(R) ASO, K-ASSAY(R) ASO Calibrator, K-ASSAY(R) ASO/RF/CRP Control and more

Devices it lists

Device	Product code	Class	Role	Source
Albumin, Antigen, Antiserum, Control	DCF	2	Manufacturer	accessdata.fda.gov
Alpha-1 Microglobulin, Antigen, Antiserum, Control	MGA	1	Repackager or relabeler	accessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	LKL	1	Manufacturer	accessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	2	Manufacturer	accessdata.fda.gov
Alpha-1-Lipoprotein, Antigen, Antiserum, Control	DER	2	Manufacturer	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Manufacturer	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Repackager or relabeler	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Complement C3, Antigen, Antiserum, Control	CZW	2	Manufacturer	accessdata.fda.gov
Complement C4, Antigen, Antiserum, Control	DBI	2	Manufacturer	accessdata.fda.gov
Factor Xiii A, S, Antigen, Antiserum, Control	DBT	1	Manufacturer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Repackager or relabeler	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Manufacturer	accessdata.fda.gov
Fibrin Split Products	GHH	2	Manufacturer	accessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	DAP	2	Manufacturer	accessdata.fda.gov
Haptoglobin, Antigen, Antiserum, Control	DAD	2	Manufacturer	accessdata.fda.gov
Igg, Antigen, Antiserum, Control	DEW	2	Manufacturer	accessdata.fda.gov
Immunoelectrophoretic, Immunoglobulins, (G, A, M)	CFF	2	Manufacturer	accessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Plasma, Coagulation Control	GGN	2	Repackager or relabeler	accessdata.fda.gov
Prealbumin, Antigen, Antiserum, Control	JZJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Manufacturer	accessdata.fda.gov
Test, Cystatin C	NDY	2	Manufacturer	accessdata.fda.gov
Test, Fibrinogen	GIS	2	Manufacturer	accessdata.fda.gov
Transferrin, Antigen, Antiserum, Control	DDG	2	Manufacturer	accessdata.fda.gov
Urinalysis Controls (Assayed And Unassayed)	JJW	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 18, 2025	K242170	K-ASSAY CRP (Ver.2)	DCK	Substantially Equivalent	Kamiya Biomedical Company, LLC	accessdata.fda.gov
May 20, 2020	K192727	K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)	DHR	Substantially Equivalent	Kamiya Biomedical Company	accessdata.fda.gov
April 27, 2011	K103557	DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET	DCK	Substantially Equivalent	Diazyme Laboratories	accessdata.fda.gov
September 28, 2010	K093137	K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL	NDY	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
April 29, 2010	K091486	K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR	DCF	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
December 23, 2005	K050944	K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET	DBF	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
August 6, 2003	K031539	HEMOGLOBIN A1C REAGENT SET	LCP	Substantially Equivalent	Pointe Scientific, Inc.,	accessdata.fda.gov
June 27, 2003	K030687	K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C	DAP	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
February 4, 2003	K023828	K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR	DCK	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
December 13, 2002	K023853	K-ASSAY LP(A) CONTROLS	DFC	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
July 25, 2002	K021660	K-ASSAY LP(A) ASSAY	DFC	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
March 24, 2000	K000679	THROMBOSTRATE CONTROL PLASMAS	GGN	Substantially Equivalent	Pacific Hemostasis	accessdata.fda.gov
December 27, 1999	K993853	K-ASSAY MULTI-ANALYTE CALIBRATOR	JIX	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
December 6, 1999	K993482	K-ASSAY FIBRINOGEN	GIS	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 30, 1999	K993537	K-ASSAY TRANSFERRIN	DDG	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 30, 1999	K993323	K-ASSAY IGM	CFF	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 29, 1999	K993481	K-ASSAY C4	DBI	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 26, 1999	K993606	K-ASSAY APO A1/B CALIBRATOR SET	JIX	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 24, 1999	K993480	K-ASSAY HAPTOGLOBIN	DAD	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 24, 1999	K993444	K-ASSAY ALPHA-1 AT	DEM	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 24, 1999	K993441	K-ASSAY ALPHA-1 AG	LKL	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 24, 1999	K993437	K-ASSAY C3	CZW	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 23, 1999	K993213	K-ASSAY IGA	CFF	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
November 9, 1999	K993281	K-ASSAY IGG	DEW	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
October 28, 1999	K993354	K-ASSAY APO B	DER	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
October 25, 1999	K993345	K-ASSAY APO AI	DER	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
May 14, 1999	K991224	K-ASSAY CRP	DCK	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
May 11, 1999	K991210	K-ASSAY CRP CALIBRATOR SET	DCK	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
September 29, 1998	K983241	ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS	JJY	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
September 29, 1998	K983130	LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS	JJY	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
August 12, 1983	K831526	URINE TOTAL PROTEIN CONTROL	JJW	Substantially Equivalent	Quantimetrix Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 28, 2022	91030	Class II	Ongoing	K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013	IgA Reagent may start showing cloudiness over time, which can affect assay performance.	accessdata.fda.gov
July 19, 2017	77916	Class II	Terminated	K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprote	The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.	accessdata.fda.gov
May 1, 2009	53750	Not yet classified	Terminated	"K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for qua	The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.	accessdata.fda.gov
September 17, 2008	50074	Not yet classified	Terminated	K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package	Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.	accessdata.fda.gov
April 11, 2006	35169	Not yet classified	Terminated	K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSA	Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent	accessdata.fda.gov
March 29, 2004	28825	Not yet classified	Terminated	K-Assay Lp(a) Control	Assay result not consistent with the assigned control value	accessdata.fda.gov

Compare with other makers

Updated April 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.