Hitachi Chemical Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Hitachi Chemical Diagnostics, Inc.” (first 2003, latest 2021), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 122 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 | 3 | 238 |
| 2013 | 7 | 59 |
| 2014 | 1 | 40 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 169 |
| 2020 | 0 | — |
| 2021 | 1 | 662 |
| 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 Hitachi Chemical Diagnostics, Inc. took a median 416 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 5 | 5 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| JFJ | Catalytic Methods, Amylase | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (10)
- Immunology (6)
Most recent Hitachi Chemical Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193613 | Allergen-Specific IgE Assay 12 Allergen Bundle | DHB | 2021-10-18 | 662 |
| K182793 | AP3600 Automated Instrument | DHB | 2019-03-19 | 169 |
| K140248 | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | KHS | 2014-03-11 | 40 |
| K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | CDN | 2013-10-28 | 82 |
| K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | JFJ | 2013-08-09 | 149 |
| K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | CIG | 2013-06-07 | 38 |
| K131051 | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | JGQ | 2013-06-07 | 53 |
| K120945 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST | CKA | 2013-06-07 | 435 |
| K130870 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) | CIC | 2013-05-02 | 34 |
| K130141 | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | CJE | 2013-03-22 | 59 |
6 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-12-21.
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.
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.
- Hitachi Medical Systems America, Inc. (100 510(k)s)
- Hitachi Medical Corp. of America (32 510(k)s)
- Hitachi Healthcare Americas (17 510(k)s)
- Hitachi Medical Corp. (12 510(k)s)
- Hitachi , Ltd. (8 510(k)s)
- Hitachi Aloka Medical, Ltd. (6 510(k)s)
- Hitachi, Ltd., Health Care Company (4 510(k)s)
- Hitachi Aloka Medical America, Inc. (3 510(k)s)
- Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical (3 510(k)s)
- Hitachi, Ltd., Power Systems Group (2 510(k)s)
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha (2 510(k)s)
- Hitachi Sales Corporation of America (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hitachi Chemical Diagnostics, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Hitachi Chemical Diagnostics, Inc.” (first 2003, latest 2021), across 12 product codes in 2 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 Hitachi Chemical Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hitachi Chemical Diagnostics, Inc. is 122 days.
Which FDA product codes appear under Hitachi Chemical Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 5); CDN (Urease, Photometric, Urea Nitrogen, 1); CFR (Hexokinase, Glucose, 1).
Next steps
- See all 16 Hitachi Chemical Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHB, Hitachi Chemical Diagnostics, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.