Kamiya Biomedical Co.
Medical device manufacturer in Tukwila, WA.
46510(k) clearances
0PMA approvals
4recalls
Device types
- DCK C-Reactive Protein, Antigen, Antiserum, And… 9
- DHR System, Test, Rheumatoid Factor 4
- DBF Ferritin, Antigen, Antiserum, Control 3
- JIX Calibrator, Multi-Analyte Mixture 3
- JJY Multi-Analyte Controls, All Kinds (Assayed) 2
- DFC Lipoprotein, Low-Density, Antigen… 2
- DAP Fibrinogen And Fibrin Split Products… 2
- CFF Immunoelectrophoretic, Immunoglobulins, (G… 2
- DER Alpha-1-Lipoprotein, Antigen, Antiserum… 2
- DEW Igg, Antigen, Antiserum, Control 1
- DDR Myoglobin, Antigen, Antiserum, Control 1
- CZW Complement C3, Antigen, Antiserum, Control 1
- LKL Alpha-1-Acid-Glycoprotein, Antigen… 1
- DEM Alpha-1-Antitrypsin, Antigen, Antiserum… 1
- DAD Haptoglobin, Antigen, Antiserum, Control 1
- DBI Complement C4, Antigen, Antiserum, Control 1
- NDY Test, Cystatin C 1
- GIS Test, Fibrinogen 1
- JBQ Antithrombin Iii Quantitation 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2)DCK · Traditional | 04/18/2025SE |
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR · Traditional | 05/20/2020SE |
| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | 05/24/2012SE |
| K093137 | K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional | 09/28/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | 04/29/2010SE |
| K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetDBF · Traditional | 12/23/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | 12/10/2004SE |
| K030687 | K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models KAI-090; KAJ-091CDAP · Traditional | 06/27/2003SE |
| K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…DCK · Traditional | 02/04/2003SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | 12/13/2002SE |
| K022486 | K-Assay Hs-Crp ControlsDCK · Traditional | 08/14/2002SE |
| K021660 | K-Assay Lp(A) AssayDFC · Traditional | 07/25/2002SE |
| K014293 | K-Assay Ferritin, K-Assay Ferritin Calibrator SetDBF · Traditional | 02/19/2002SE |
| K012422 | K-Assay D-Dimer ControlsGGC · Traditional | 08/21/2001SE |
| K011780 | K-Assay C1-INADBA · Traditional | 07/25/2001SE |
| K002948 | K-Assay D-Dimer with Calibrator Set and Calibrator DiluentDAP · Traditional | 05/18/2001SE |
| K011079 | K-Assay Hs-Crp ControlsDCK · Traditional | 05/16/2001SE |
| K002558 | K-Assay High Sensitive CRP(2) for the Beckman Coulter ImmageDCK · Special | 10/25/2000SE |
| K000361 | K-Assay At-IiiJBQ · Traditional | 04/26/2000SE |
| K993853 | K-Assay Multi-Analyte CalibratorJIX · Traditional | 12/27/1999SE |
| K993482 | K-Assay FibrinogenGIS · Traditional | 12/06/1999SE |
| K993537 | K-Assay TransferrinDDG · Traditional | 11/30/1999SE |
| K993323 | K-Assay IgmCFF · Traditional | 11/30/1999SE |
| K993481 | K-Assay C4DBI · Traditional | 11/29/1999SE |
| K993606 | K-Assay Apo A1/B Calibrator SetJIX · Traditional | 11/26/1999SE |
| K993480 | K-Assay HaptoglobinDAD · Traditional | 11/24/1999SE |
| K993444 | K-Assay ALPHA-1 atDEM · Traditional | 11/24/1999SE |
| K993441 | K-Assay ALPHA-1 AGLKL · Traditional | 11/24/1999SE |
| K993437 | K-Assay C3CZW · Traditional | 11/24/1999SE |
| K993213 | K-Assay IgaCFF · Traditional | 11/23/1999SE |
| K993281 | K-Assay IggDEW · Traditional | 11/09/1999SE |
| K992976 | K-Assay Myoglobin Assay, K-Assay Myoglobin CalibratorDDR · Traditional | 11/01/1999SE |
| K993354 | K-Assay Apo BDER · Traditional | 10/28/1999SE |
| K993345 | K-Assay Apo AiDER · Traditional | 10/25/1999SE |
| K992312 | K-Assay CRP (2), K-Assay CRP Multi-Calibrator a, K-Assay CRP Multi-Calibrator BDCK · Traditional | 09/13/1999SE |
| K992311 | K-Assay CRP(1), K-Assay CRP Multi-Calibrator a, K-Assay CRP Multi-CalibratorcDCK · Traditional | 09/13/1999SE |
| K990581 | Direct Hdl-Cholesterol ReagentLBS · Traditional | 06/18/1999SE |
| K991467 | K-Assay Rheumatoid Factor Calibrator SetDHR · Traditional | 06/10/1999SE |
| K991166 | K-Assay Microalbumin Calibrator SetJIX · Traditional | 06/10/1999SE |
| K991409 | K-Assay Rheumatoid FactorDHR · Traditional | 06/09/1999SE |
| K991224 | K-Assay CRPDCK · Traditional | 05/14/1999SE |
| K991210 | K-Assay CRP Calibrator SetDCK · Traditional | 05/11/1999SE |
| K984045 | RF Control for Immunoturbidimetric AssaysDHR · Traditional | 01/25/1999SE |
| K983241 | Aso/Crp/Rf Controls for Immunoturbidimetric AssaysJJY · Traditional | 09/29/1998SE |
| K983130 | Liquid Immunology Controls for Immunoturbidimetric AssaysJJY · Traditional | 09/29/1998SE |
| K905829 | Determiner Pl/Determination of PhospholipidsCEL · Traditional | 01/30/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0271-2023 Class II | K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013IgA Reagent may start showing cloudiness over time, which can affect assay performance. | 09/28/2022Open, Classified |
| Z-3138-2017 Class II | K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle…The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and… | 07/19/2017Terminated |
| Z-0973-2010 | "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated…The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP… | 05/01/2009Terminated |
| Z-0923-2011 | K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL…Standardization of the reagent performance data did not match the standardization used to assign the… | 09/17/2008Terminated |