K070929 is an FDA 510(k) clearance for the ACON U120 URINE ANALYZER, MODEL U111-101. This device is classified as a Automated Urinalysis System (Class I - General Controls, product code KQO).
Submitted by ACON Laboratories, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 30, 2007, 118 days after receiving the submission on April 3, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2900.
| 510(k) Number | K070929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2007 |
| Decision Date | July 30, 2007 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KQO — Automated Urinalysis System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2900 |