Submission Details
| 510(k) Number | K142543 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 10, 2014 |
| Decision Date | May 11, 2015 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
May 2015
Decision
243d
Days
Class 1
Risk
About This 510(k) Submission
K142543 is an FDA 510(k) clearance for the Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 11, 2015, 243 days after receiving the submission on September 10, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.
Device Classification
| Product Code | KQO — Automated Urinalysis System |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2900 |
Manufacturer
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