Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Kamiya Biomedical Co. — Predicate Candidate Screening

43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

48 daysmedian FDA review time

115 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K093137	K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL	Kamiya Biomedical Co.	2010-09-28	358	0
K091486	K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR	Kamiya Biomedical Co.	2010-04-29	345	0
K050944	K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET	Kamiya Biomedical Co.	2005-12-23	253	0
K042241	K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-09	Kamiya Biomedical Co.	2004-12-10	113	0
K030687	K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090;	Kamiya Biomedical Co.	2003-06-27	114	0
K023828	K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR	Kamiya Biomedical Co.	2003-02-04	78	1
K023853	K-ASSAY LP(A) CONTROLS	Kamiya Biomedical Co.	2002-12-13	24	1
K022486	K-ASSAY HS-CRP CONTROLS	Kamiya Biomedical Co.	2002-08-14	16	0
K021660	K-ASSAY LP(A) ASSAY	Kamiya Biomedical Co.	2002-07-25	66	0
K014293	K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET	Kamiya Biomedical Co.	2002-02-19	53	0
K012422	K-ASSAY D-DIMER CONTROLS	Kamiya Biomedical Co.	2001-08-21	22	0
K011780	K-ASSAY C1-INA	Kamiya Biomedical Co.	2001-07-25	48	0
K002948	K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT	Kamiya Biomedical Co.	2001-05-18	239	0
K011079	K-ASSAY HS-CRP CONTROLS	Kamiya Biomedical Co.	2001-05-16	37	0
K002558	K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE	Kamiya Biomedical Co.	2000-10-25	72	0
K000361	K-ASSAY AT-III	Kamiya Biomedical Co.	2000-04-26	82	0
K993853	K-ASSAY MULTI-ANALYTE CALIBRATOR	Kamiya Biomedical Co.	1999-12-27	45	0
K993482	K-ASSAY FIBRINOGEN	Kamiya Biomedical Co.	1999-12-06	53	0
K993323	K-ASSAY IGM	Kamiya Biomedical Co.	1999-11-30	57	0
K993537	K-ASSAY TRANSFERRIN	Kamiya Biomedical Co.	1999-11-30	42	0
K993481	K-ASSAY C4	Kamiya Biomedical Co.	1999-11-29	46	0
K993606	K-ASSAY APO A1/B CALIBRATOR SET	Kamiya Biomedical Co.	1999-11-26	32	0
K993480	K-ASSAY HAPTOGLOBIN	Kamiya Biomedical Co.	1999-11-24	41	0
K993437	K-ASSAY C3	Kamiya Biomedical Co.	1999-11-24	43	0
K993444	K-ASSAY ALPHA-1 AT	Kamiya Biomedical Co.	1999-11-24	43	0
K993441	K-ASSAY ALPHA-1 AG	Kamiya Biomedical Co.	1999-11-24	43	0
K993213	K-ASSAY IGA	Kamiya Biomedical Co.	1999-11-23	60	1
K993281	K-ASSAY IGG	Kamiya Biomedical Co.	1999-11-09	40	0
K992976	K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR	Kamiya Biomedical Co.	1999-11-01	59	0
K993354	K-ASSAY APO B	Kamiya Biomedical Co.	1999-10-28	23	0
K993345	K-ASSAY APO AI	Kamiya Biomedical Co.	1999-10-25	20	0
K992311	K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP	Kamiya Biomedical Co.	1999-09-13	66	0
K992312	K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP	Kamiya Biomedical Co.	1999-09-13	66	1
K990581	DIRECT HDL-CHOLESTEROL REAGENT	Kamiya Biomedical Co.	1999-06-18	115	0
K991166	K-ASSAY MICROALBUMIN CALIBRATOR SET	Kamiya Biomedical Co.	1999-06-10	64	0
K991467	K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET	Kamiya Biomedical Co.	1999-06-10	44	0
K991409	K-ASSAY RHEUMATOID FACTOR	Kamiya Biomedical Co.	1999-06-09	48	0
K991224	K-ASSAY CRP	Kamiya Biomedical Co.	1999-05-14	32	0
K991210	K-ASSAY CRP CALIBRATOR SET	Kamiya Biomedical Co.	1999-05-11	32	0
K984045	RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS	Kamiya Biomedical Co.	1999-01-25	73	0
K983130	LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS	Kamiya Biomedical Co.	1998-09-29	21	0
K983241	ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS	Kamiya Biomedical Co.	1998-09-29	14	0
K905829	DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS	Kamiya Biomedical Co.	1991-01-30	30	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda