K142391 is an FDA 510(k) clearance for the Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ). This device is classified as a Enzymatic Method, Creatinine (Class II - Special Controls, product code JFY).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on December 22, 2014, 117 days after receiving the submission on August 27, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K142391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2014 |
| Decision Date | December 22, 2014 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |