Kyoto Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Kyoto Diagnostics, Inc.” (first 1984, latest 1986), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 54 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 4 | 4 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | 1 |
| JJM | Osmometer For Clinical Use | 1 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 | 1 |
| JRE | Refractometer For Clinical Use | 1 | 1 |
| KQO | Automated Urinalysis System | 1 | 1 |
Review panels
- Clinical Chemistry (11)
Most recent Kyoto Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861733 | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS | JIL | 1986-07-25 | 80 |
| K843003 | GLUCOSE AUTO& STAT GA-1120 | CGA | 1984-09-28 | 60 |
| K842750 | OSMOTIC PRESSURE AUTO & STAT OM-6010 | JJM | 1984-08-17 | 35 |
| K842168 | ATAGO URINE SPECIFIC GRAVITY & SERUM | JRE | 1984-07-16 | 46 |
| K841715 | KYOTEST UK URINE TEST REAGENT STRIP | JIN | 1984-05-31 | 37 |
| K841714 | KYOTEST 2V, URINE TEST REAGENT STRIP | JIL | 1984-05-31 | 37 |
| K841713 | KYOTEST UG URINE TEST REAGENT STRIP | JIL | 1984-05-31 | 37 |
| K840828 | KYOTEST 8V | JMT | 1984-05-14 | 80 |
| K840827 | KYOTEST 5V | CEN | 1984-05-14 | 80 |
| K840996 | URINE ANALYZER SYSTEM | KQO | 1984-05-01 | 54 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kyoto Diagnostics, Inc..
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.
- Kyoto Daiichi Kagaku Co., Ltd. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kyoto Diagnostics, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Kyoto Diagnostics, Inc.” (first 1984, latest 1986), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kyoto Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kyoto Diagnostics, Inc. is 54 days.
Which FDA product codes appear under Kyoto Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 4); CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative), 1); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 11 Kyoto Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIL, Kyoto 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.