K120124 is an FDA 510(k) clearance for the FORESIGHT U120 URINE ANALYZER. This device is classified as a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II - Special Controls, product code JIL).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on March 6, 2012, 49 days after receiving the submission on January 17, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1340.
| 510(k) Number | K120124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2012 |
| Decision Date | March 06, 2012 |
| Days to Decision | 49 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1340 |