Company · US

Kamiya Biomedical Co.

FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2025. Name variants (Inc, Corp, punctuation) are merged.

46510(k) clearances (0 in 12 months)

6recalls (0 in 12 months)

5recalls that name a 510(k)

Product codes

Code	Device	Records
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	11
DHR	System, Test, Rheumatoid Factor	4
JIX	Calibrator, Multi-Analyte Mixture	4
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	3
DBF	Ferritin, Antigen, Antiserum, Control	3
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	3
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	2
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	2
JJY	Multi-Analyte Controls, All Kinds (Assayed)	2
CEL	Ammonium Molybdate And Ammonium Vanadate, Phospholipids	1
CZW	Complement C3, Antigen, Antiserum, Control	1
DAD	Haptoglobin, Antigen, Antiserum, Control	1
DBA	Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control	1
DBI	Complement C4, Antigen, Antiserum, Control	1
DCF	Albumin, Antigen, Antiserum, Control	1
DDG	Transferrin, Antigen, Antiserum, Control	1
DDR	Myoglobin, Antigen, Antiserum, Control	1
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	1
DEW	Igg, Antigen, Antiserum, Control	1
DGC	Ige, Antigen, Antiserum, Control	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Apr 18, 2025	K242170	K-ASSAY CRP (Ver.2) Kamiya Biomedical Company, LLC	DCK
May 20, 2020	K192727	K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) Kamiya Biomedical Company	DHR
May 24, 2012	K121232	K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR Kamiya Biomedical Company	DBF
Sep 28, 2010	K093137	K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL Kamiya Biomedical Co.	NDY
Apr 29, 2010	K091486	K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR Kamiya Biomedical Co.	DCF
Dec 23, 2005	K050944	K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET Kamiya Biomedical Co.	DBF
Dec 10, 2004	K042241	K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C Kamiya Biomedical Co.	DGC
Jun 27, 2003	K030687	K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C Kamiya Biomedical Co.	DAP
Feb 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 Kamiya Biomedical Co.	DCK
Dec 13, 2002	K023853	K-ASSAY LP(A) CONTROLS Kamiya Biomedical Co.	DFC
Aug 14, 2002	K022486	K-ASSAY HS-CRP CONTROLS Kamiya Biomedical Co.	DCK
Jul 25, 2002	K021660	K-ASSAY LP(A) ASSAY Kamiya Biomedical Co.	DFC
Feb 19, 2002	K014293	K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET Kamiya Biomedical Co.	DBF
Aug 21, 2001	K012422	K-ASSAY D-DIMER CONTROLS Kamiya Biomedical Co.	GGC
Jul 25, 2001	K011780	K-ASSAY C1-INA Kamiya Biomedical Co.	DBA
May 18, 2001	K002948	K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT Kamiya Biomedical Co.	DAP
May 16, 2001	K011079	K-ASSAY HS-CRP CONTROLS Kamiya Biomedical Co.	DCK
Oct 25, 2000	K002558	K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE Kamiya Biomedical Co.	DCK
Apr 26, 2000	K000361	K-ASSAY AT-III Kamiya Biomedical Co.	JBQ
Dec 27, 1999	K993853	K-ASSAY MULTI-ANALYTE CALIBRATOR Kamiya Biomedical Co.	JIX
Dec 6, 1999	K993482	K-ASSAY FIBRINOGEN Kamiya Biomedical Co.	GIS
Nov 30, 1999	K993537	K-ASSAY TRANSFERRIN Kamiya Biomedical Co.	DDG
Nov 30, 1999	K993323	K-ASSAY IGM Kamiya Biomedical Co.	CFF
Nov 29, 1999	K993481	K-ASSAY C4 Kamiya Biomedical Co.	DBI
Nov 26, 1999	K993606	K-ASSAY APO A1/B CALIBRATOR SET Kamiya Biomedical Co.	JIX
Nov 24, 1999	K993480	K-ASSAY HAPTOGLOBIN Kamiya Biomedical Co.	DAD
Nov 24, 1999	K993444	K-ASSAY ALPHA-1 AT Kamiya Biomedical Co.	DEM
Nov 24, 1999	K993441	K-ASSAY ALPHA-1 AG Kamiya Biomedical Co.	LKL
Nov 24, 1999	K993437	K-ASSAY C3 Kamiya Biomedical Co.	CZW
Nov 23, 1999	K993213	K-ASSAY IGA Kamiya Biomedical Co.	CFF
Nov 9, 1999	K993281	K-ASSAY IGG Kamiya Biomedical Co.	DEW
Nov 1, 1999	K992976	K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR Kamiya Biomedical Co.	DDR
Oct 28, 1999	K993354	K-ASSAY APO B Kamiya Biomedical Co.	DER
Oct 25, 1999	K993345	K-ASSAY APO AI Kamiya Biomedical Co.	DER
Sep 13, 1999	K992312	K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B Kamiya Biomedical Co.	DCK
Sep 13, 1999	K992311	K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC Kamiya Biomedical Co.	DCK
Jun 18, 1999	K990581	DIRECT HDL-CHOLESTEROL REAGENT Kamiya Biomedical Co.	LBS
Jun 10, 1999	K991467	K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET Kamiya Biomedical Co.	DHR
Jun 10, 1999	K991166	K-ASSAY MICROALBUMIN CALIBRATOR SET Kamiya Biomedical Co.	JIX
Jun 9, 1999	K991409	K-ASSAY RHEUMATOID FACTOR Kamiya Biomedical Co.	DHR
May 14, 1999	K991224	K-ASSAY CRP Kamiya Biomedical Co.	DCK
May 11, 1999	K991210	K-ASSAY CRP CALIBRATOR SET Kamiya Biomedical Co.	DCK
Jan 25, 1999	K984045	RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS Kamiya Biomedical Co.	DHR
Sep 29, 1998	K983241	ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS Kamiya Biomedical Co.	JJY
Sep 29, 1998	K983130	LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS Kamiya Biomedical Co.	JJY
Jan 30, 1991	K905829	DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS Kamiya Biomedical Co.	CEL

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Nov 21, 2022	Kamiya Biomedical Company, LLC K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 Open, Classified	CFF	K993213
Jul 19, 2017	Kamiya Biomedical Company, LLC 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) Al Terminated	JIX	K993853
Jan 19, 2011	Kamiya Biomedical Company, LLC 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 packag Terminated	MGA	None listed
Mar 4, 2010	Kamiya Biomedical Company, LLC "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) immunoturbi Terminated	DCK	K023828
May 6, 2006	Kamiya Biomedical Company 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 Terminated	DCK	K992312
Jul 20, 2004	Kamiya Biomedical Company K-Assay Lp(a) Control Terminated	DFC	K023853

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