The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon U120 Urine Analyzer, Model U111-101.
| Device ID | K070929 |
| 510k Number | K070929 |
| Device Name: | ACON U120 URINE ANALYZER, MODEL U111-101 |
| Classification | Automated Urinalysis System |
| Applicant | ACON LABORATORIES, INC. 4139 GARDENDALE CENTER, #101 San Antonio, TX 78229 |
| Contact | Martin O'connor |
| Correspondent | Martin O'connor ACON LABORATORIES, INC. 4139 GARDENDALE CENTER, #101 San Antonio, TX 78229 |
| Product Code | KQO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-03 |
| Decision Date | 2007-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00682607000265 | K070929 | 000 |
| 00722066001936 | K070929 | 000 |
| 10607415002062 | K070929 | 000 |
| 10607415002055 | K070929 | 000 |
| 10607415001294 | K070929 | 000 |