Kamiya Biomedical Co.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under 2 spellings of the applicant name “Kamiya Biomedical Co.” (first 1991, latest 2020), across 26 product codes in 3 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 30 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 236 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kamiya Biomedical Co. took a median 236 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 179 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 8 | 8 |
| DHR | System, Test, Rheumatoid Factor | 4 | 4 |
| DBF | Ferritin, Antigen, Antiserum, Control | 3 | 3 |
| JIX | Calibrator, Multi-Analyte Mixture | 3 | 3 |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | 2 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 2 | 2 |
| DER | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | 2 | 2 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| CEL | Ammonium Molybdate And Ammonium Vanadate, Phospholipids | 1 | 1 |
Plus 16 more product codes.
Review panels
- Immunology (32)
- Clinical Chemistry (8)
- Hematology (5)
Most recent Kamiya Biomedical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | DHR | 2020-05-20 | 236 |
| K121232 | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | DBF | 2012-05-24 | 30 |
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | NDY | 2010-09-28 | 358 |
| K091486 | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | DCF | 2010-04-29 | 345 |
| K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | DBF | 2005-12-23 | 253 |
| K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | DGC | 2004-12-10 | 113 |
| K030687 | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C | DAP | 2003-06-27 | 114 |
| 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 | 2003-02-04 | 78 |
| K023853 | K-ASSAY LP(A) CONTROLS | DFC | 2002-12-13 | 24 |
| K022486 | K-ASSAY HS-CRP CONTROLS | DCK | 2002-08-14 | 16 |
35 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2006-04-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Kamiya Biomedical Co. (a text match, not an official crosswalk):
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Kamiya Biomedical Co. (43)
- Kamiya Biomedical Company (2)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kamiya Tsusan Kaisha, Ltd. (4 510(k)s)
- Kamiya Technology Services (2 510(k)s)
- Kamiya Biomedical Company, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kamiya Biomedical Co.?
FDA lists 45 510(k) clearances under 2 spellings of the applicant name “Kamiya Biomedical Co.” (first 1991, latest 2020), across 26 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kamiya Biomedical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kamiya Biomedical Co. is 48 days.
Which FDA product codes appear under Kamiya Biomedical Co.?
The most frequent FDA product codes under this applicant name are DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 8); DHR (System, Test, Rheumatoid Factor, 4); DBF (Ferritin, Antigen, Antiserum, Control, 3).
Next steps
- See all 45 Kamiya Biomedical Co. clearances with predicates and recalls
- Run predicate analysis for product code DCK, Kamiya Biomedical Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.