K831499 is an FDA 510(k) clearance for the GLUCOSE 3, INLAB REAGENT STRIPS-URINALY. This device is classified as a Nitroprusside, Ketones (urinary, Non-quant.) (Class I - General Controls, product code JIN).
Submitted by Laprol Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1983, 37 days after receiving the submission on May 11, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1435.
| 510(k) Number | K831499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1983 |
| Decision Date | June 17, 1983 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIN — Nitroprusside, Ketones (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1435 |