The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/creatinine ).
| Device ID | K142391 |
| 510k Number | K142391 |
| Device Name: | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) |
| Classification | Enzymatic Method, Creatinine |
| Applicant | ACON LABORATORIES, INC. 10125 MESA RIM ROAD San Diego, CA 92121 |
| Contact | Qiyi Xie |
| Correspondent | Qiyi Xie ACON LABORATORIES, INC. 10125 MESA RIM ROAD San Diego, CA 92121 |
| Product Code | JFY |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJW |
| Subsequent Product Code | KQO |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-27 |
| Decision Date | 2014-12-22 |
| Summary: | summary |