Kyoto Diagnostics, Inc.
Walker, MI, US
Kyoto Diagnostics, Inc. appears in FDA device records in Walker, MI. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Kyoto Diagnostics, Inc. between 1984 and 1986. The busiest year on record is 1984, with 10. The most recent is 1986, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 10 |
| 1986 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K861733 | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS | JIL | Substantially Equivalent | |
| K843003 | GLUCOSE AUTO& STAT GA-1120 | CGA | Substantially Equivalent | |
| K842750 | OSMOTIC PRESSURE AUTO & STAT OM-6010 | JJM | Substantially Equivalent | |
| K842168 | ATAGO URINE SPECIFIC GRAVITY & SERUM | JRE | Substantially Equivalent | |
| K841715 | KYOTEST UK URINE TEST REAGENT STRIP | JIN | Substantially Equivalent | |
| K841714 | KYOTEST 2V, URINE TEST REAGENT STRIP | JIL | Substantially Equivalent | |
| K841713 | KYOTEST UG URINE TEST REAGENT STRIP | JIL | Substantially Equivalent | |
| K840828 | KYOTEST 8V | JMT | Substantially Equivalent | |
| K840827 | KYOTEST 5V | CEN | Substantially Equivalent | |
| K840996 | URINE ANALYZER SYSTEM | KQO | Substantially Equivalent | |
| K840829 | KYOTEST UGK | JIL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KQOAutomated Urinalysis System
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CGAGlucose Oxidase, Glucose
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- JJMOsmometer For Clinical Use
- JRERefractometer For Clinical Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain