Medical Device Manufacturer · US , Thousand Oaks , CA

Kamiya Biomedical Co.

43 submissions · 43 cleared · Since 1991
43
Total
43
Cleared
0
Denied

Kamiya Biomedical Co. — FDA 510(k) Submissions

Kamiya Biomedical Co. has submitted 43 FDA 510(k) premarket notifications since 1991, of which 43 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include C-reactive Protein, Antigen, Antiserum, And Control, System, Test, Rheumatoid Factor, Calibrator, Multi-analyte Mixture, Ferritin, Antigen, Antiserum, Control, Immunoelectrophoretic, Immunoglobulins, (g, A, M) . Use the specialty filter in the sidebar to narrow results.

43 devices
1–25 of 43
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
K093137 · NDY Test, Cystatin C · Chemistry
Sep 2010 358d
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
K091486 · DCF Albumin, Antigen,... · Chemistry
Apr 2010 345d
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
K050944 · DBF Ferritin, Antigen,... · Immunology
Dec 2005 253d
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
K042241 · DGC Ige, Antigen, Antiserum,... · Immunology
Dec 2004 113d
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
K030687 · DAP Fibrinogen And Fibrin... · Hematology
Jun 2003 114d
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
K023828 · DCK C-reactive Protein,... · Immunology
Feb 2003 78d
K-ASSAY LP(A) CONTROLS
K023853 · DFC Lipoprotein, Low-density,... · Immunology
Dec 2002 24d
K-ASSAY HS-CRP CONTROLS
K022486 · DCK C-reactive Protein,... · Immunology
Aug 2002 16d
K-ASSAY LP(A) ASSAY
K021660 · DFC Lipoprotein, Low-density,... · Chemistry
Jul 2002 66d
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
K014293 · DBF Ferritin, Antigen,... · Immunology
Feb 2002 53d
K-ASSAY D-DIMER CONTROLS
K012422 · GGC Control, Plasma, Abnormal · Hematology
Aug 2001 22d
K-ASSAY C1-INA
K011780 · DBA Complement C1 Inhibitor... · Immunology
Jul 2001 48d
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948 · DAP Fibrinogen And Fibrin... · Hematology
May 2001 239d
K-ASSAY HS-CRP CONTROLS
K011079 · DCK C-reactive Protein,... · Immunology
May 2001 37d
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
K002558 · DCK C-reactive Protein,... · Immunology
Oct 2000 72d
K-ASSAY AT-III
K000361 · JBQ Antithrombin Iii... · Hematology
Apr 2000 82d
K-ASSAY MULTI-ANALYTE CALIBRATOR
K993853 · JIX Calibrator, Multi-analyte... · Chemistry
Dec 1999 45d
K-ASSAY FIBRINOGEN
K993482 · GIS Test, Fibrinogen · Hematology
Dec 1999 53d
K-ASSAY IGM
K993323 · CFF Immunoelectrophoretic,... · Immunology
Nov 1999 57d
K-ASSAY TRANSFERRIN
K993537 · DDG Transferrin, Antigen,... · Immunology
Nov 1999 42d
K-ASSAY C4
K993481 · DBI Complement C4, Antigen,... · Immunology
Nov 1999 46d
K-ASSAY APO A1/B CALIBRATOR SET
K993606 · JIX Calibrator, Multi-analyte... · Chemistry
Nov 1999 32d
K-ASSAY C3
K993437 · CZW Complement C3, Antigen,... · Immunology
Nov 1999 43d
K-ASSAY ALPHA-1 AG
K993441 · LKL Alpha-1-acid-glycoprotein... · Immunology
Nov 1999 43d
K-ASSAY ALPHA-1 AT
K993444 · DEM Alpha-1-antitrypsin,... · Immunology
Nov 1999 43d
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