The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Foresight U120 Urine Analyzer.
| Device ID | K120124 |
| 510k Number | K120124 |
| Device Name: | FORESIGHT U120 URINE ANALYZER |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| 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 | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479183634 | K120124 | 000 |
| 40612479197204 | K120124 | 000 |
| 40612479183665 | K120124 | 000 |
| 40612479183658 | K120124 | 000 |
| 40612479183641 | K120124 | 000 |
| 10722066004415 | K120124 | 000 |
| 10722066004408 | K120124 | 000 |