K843757 is an FDA 510(k) clearance for the UROPAPER EIKEN AG. This device is classified as a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II - Special Controls, product code JIL).
Submitted by Syn-Kit, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1984, 84 days after receiving the submission on September 25, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1340.
| 510(k) Number | K843757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1984 |
| Decision Date | December 18, 1984 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1340 |