Submission Details
| 510(k) Number | K111221 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 02, 2011 |
| Decision Date | January 18, 2012 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
MISSION U500 URINE ANALYZER
Jan 2012
Decision
261d
Days
Class 2
Risk
About This 510(k) Submission
K111221 is an FDA 510(k) clearance for the MISSION U500 URINE ANALYZER, a Blood, Occult, Colorimetric, In Urine (Class II — Special Controls, product code JIO), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on January 18, 2012, 261 days after receiving the submission on May 2, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.6550.
Device Classification
| Product Code | JIO — Blood, Occult, Colorimetric, In Urine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.6550 |
Manufacturer
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