The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Uropaper Eiken 6b.
| Device ID | K843755 |
| 510k Number | K843755 |
| Device Name: | UROPAPER EIKEN 6B |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Contact | Iwao Matsuoka |
| Correspondent | Iwao Matsuoka SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-25 |
| Decision Date | 1984-12-18 |