Submission Details
| 510(k) Number | K142391 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
Dec 2014
Decision
117d
Days
Class 2
Risk
About This 510(k) Submission
K142391 is an FDA 510(k) clearance for the Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ), 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 review panel. Regulated under 21 CFR 862.1225.
Device Classification
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1225 |
Manufacturer
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