The following data is part of a premarket notification filed by Laprol Scientific, Inc. with the FDA for Uri-test 3, Inlab Reagent Strips-urinal.
| Device ID | K831498 |
| 510k Number | K831498 |
| Device Name: | URI-TEST 3, INLAB REAGENT STRIPS-URINAL |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | LAPROL SCIENTIFIC, 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 | 1983-05-11 |
| Decision Date | 1983-06-22 |