Company ยท US
Kyoto Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1986. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 4 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 |
| JJM | Osmometer For Clinical Use | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 |
| JRE | Refractometer For Clinical Use | 1 |
| KQO | Automated Urinalysis System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 1986 | K861733 | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS Kyoto Diagnostics, Inc. | JIL |
| Sep 28, 1984 | K843003 | GLUCOSE AUTO& STAT GA-1120 Kyoto Diagnostics, Inc. | CGA |
| Aug 17, 1984 | K842750 | OSMOTIC PRESSURE AUTO & STAT OM-6010 Kyoto Diagnostics, Inc. | JJM |
| Jul 16, 1984 | K842168 | ATAGO URINE SPECIFIC GRAVITY & SERUM Kyoto Diagnostics, Inc. | JRE |
| May 31, 1984 | K841715 | KYOTEST UK URINE TEST REAGENT STRIP Kyoto Diagnostics, Inc. | JIN |
| May 31, 1984 | K841714 | KYOTEST 2V, URINE TEST REAGENT STRIP Kyoto Diagnostics, Inc. | JIL |
| May 31, 1984 | K841713 | KYOTEST UG URINE TEST REAGENT STRIP Kyoto Diagnostics, Inc. | JIL |
| May 14, 1984 | K840828 | KYOTEST 8V Kyoto Diagnostics, Inc. | JMT |
| May 14, 1984 | K840827 | KYOTEST 5V Kyoto Diagnostics, Inc. | CEN |
| May 1, 1984 | K840996 | URINE ANALYZER SYSTEM Kyoto Diagnostics, Inc. | KQO |
| Apr 19, 1984 | K840829 | KYOTEST UGK Kyoto Diagnostics, Inc. | JIL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||