Kamiya Biomedical Company, LLC
Tukwila, WA, US
KAMIYA BIOMEDICAL COMPANY LLC appears in FDA device records in Tukwila, WA. FDA records list 46 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 46 510(k) clearances for Kamiya Biomedical Company, LLC between 1991 and 2025. The busiest year on record is 1999, with 24. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1998 | 2 |
| 1999 | 24 |
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2010 | 2 |
| 2012 | 1 |
| 2020 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2) | DCK | Substantially Equivalent | |
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | DHR | Substantially Equivalent | |
| K121232 | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | DBF | Substantially Equivalent | |
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | NDY | Substantially Equivalent | |
| K091486 | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | DCF | Substantially Equivalent | |
| K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | DBF | Substantially Equivalent | |
| K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | DGC | Substantially Equivalent | |
| K030687 | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C | DAP | Substantially Equivalent | |
| 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 | |
| K023853 | K-ASSAY LP(A) CONTROLS | DFC | Substantially Equivalent | |
| K022486 | K-ASSAY HS-CRP CONTROLS | DCK | Substantially Equivalent | |
| K021660 | K-ASSAY LP(A) ASSAY | DFC | Substantially Equivalent | |
| K014293 | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | DBF | Substantially Equivalent | |
| K012422 | K-ASSAY D-DIMER CONTROLS | GGC | Substantially Equivalent | |
| K011780 | K-ASSAY C1-INA | DBA | Substantially Equivalent | |
| K002948 | K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT | DAP | Substantially Equivalent | |
| K011079 | K-ASSAY HS-CRP CONTROLS | DCK | Substantially Equivalent | |
| K002558 | K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE | DCK | Substantially Equivalent | |
| K000361 | K-ASSAY AT-III | JBQ | Substantially Equivalent | |
| K993853 | K-ASSAY MULTI-ANALYTE CALIBRATOR | JIX | Substantially Equivalent | |
| K993482 | K-ASSAY FIBRINOGEN | GIS | Substantially Equivalent | |
| K993537 | K-ASSAY TRANSFERRIN | DDG | Substantially Equivalent | |
| K993323 | K-ASSAY IGM | CFF | Substantially Equivalent | |
| K993481 | K-ASSAY C4 | DBI | Substantially Equivalent | |
| K993606 | K-ASSAY APO A1/B CALIBRATOR SET | JIX | Substantially Equivalent | |
| K993480 | K-ASSAY HAPTOGLOBIN | DAD | Substantially Equivalent | |
| K993444 | K-ASSAY ALPHA-1 AT | DEM | Substantially Equivalent | |
| K993441 | K-ASSAY ALPHA-1 AG | LKL | Substantially Equivalent | |
| K993437 | K-ASSAY C3 | CZW | Substantially Equivalent | |
| K993213 | K-ASSAY IGA | CFF | Substantially Equivalent | |
| K993281 | K-ASSAY IGG | DEW | Substantially Equivalent | |
| K992976 | K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR | DDR | Substantially Equivalent | |
| K993354 | K-ASSAY APO B | DER | Substantially Equivalent | |
| K993345 | K-ASSAY APO AI | DER | Substantially Equivalent | |
| K992312 | K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B | DCK | Substantially Equivalent | |
| K992311 | K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC | DCK | Substantially Equivalent | |
| K990581 | DIRECT HDL-CHOLESTEROL REAGENT | LBS | Substantially Equivalent | |
| K991467 | K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET | DHR | Substantially Equivalent | |
| K991166 | K-ASSAY MICROALBUMIN CALIBRATOR SET | JIX | Substantially Equivalent | |
| K991409 | K-ASSAY RHEUMATOID FACTOR | DHR | Substantially Equivalent | |
| K991224 | K-ASSAY CRP | DCK | Substantially Equivalent | |
| K991210 | K-ASSAY CRP CALIBRATOR SET | DCK | Substantially Equivalent | |
| K984045 | RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS | DHR | Substantially Equivalent | |
| K983241 | ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS | JJY | Substantially Equivalent | |
| K983130 | LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS | JJY | Substantially Equivalent | |
| K905829 | DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS | CEL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2084025 | 2084025 | KAMIYA BIOMEDICAL COMPANY LLC | 12779 Gateway Dr S, Tukwila, WA 98168 US | 2026 | and 23 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DCFAlbumin, Antigen, Antiserum, Control
- MGAAlpha-1 Microglobulin, Antigen, Antiserum, Control
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control
- CELAmmonium Molybdate And Ammonium Vanadate, Phospholipids
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- JBQAntithrombin Iii Quantitation
- LCPAssay, Glycosylated Hemoglobin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- GGCControl, Plasma, Abnormal
- DBTFactor Xiii A, S, Antigen, Antiserum, Control
- DBFFerritin, Antigen, Antiserum, Control
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- GHHFibrin Split Products
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- DADHaptoglobin, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDRMyoglobin, Antigen, Antiserum, Control
- GGNPlasma, Coagulation Control
- JZJPrealbumin, Antigen, Antiserum, Control
- CFPRadioimmunoassay, Immunoreactive Insulin
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DHRSystem, Test, Rheumatoid Factor
- NDYTest, Cystatin C
- GISTest, Fibrinogen
- DDGTransferrin, Antigen, Antiserum, Control
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0271-2023 | K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 | IgA Reagent may start showing cloudiness over time, which can affect assay performance. | Class II | Open, Classified | |
| Z-3138-2017 | 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 Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use | The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct. | Class II | Terminated | |
| Z-0973-2010 | "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 quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use. | The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration. | Terminated | ||
| Z-0923-2011 | 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 insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...". | Standardization of the reagent performance data did not match the standardization used to assign the calibrator values. | Terminated | ||
| Z-0850-06 | 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-ASSAY CRP(2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap. | Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent | Terminated | ||
| Z-0940-04 | K-Assay Lp(a) Control | Assay result not consistent with the assigned control value | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain