The following data is part of a premarket notification filed by Kyoto Diagnostics, Inc. with the FDA for Additional Kyotest Urine Test Reagent Strips.
| Device ID | K861733 |
| 510k Number | K861733 |
| Device Name: | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | KYOTO DIAGNOSTICS, INC. 2421 SOUTH NAPPANEE ST. POST OFFICE BOX 4226 Elkhart, IN 46514 |
| Contact | Jackson, Ph.d. |
| Correspondent | Jackson, Ph.d. KYOTO DIAGNOSTICS, INC. 2421 SOUTH NAPPANEE ST. POST OFFICE BOX 4226 Elkhart, IN 46514 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-07-25 |