K063295 is an FDA 510(k) clearance for the ACON UTI URINARY TRACT INFECTION TEST STRIPS. This device is classified as a Test, Urine Leukocyte (Class I - General Controls, product code LJX).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on October 12, 2007, 345 days after receiving the submission on November 1, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7675.
| 510(k) Number | K063295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2006 |
| Decision Date | October 12, 2007 |
| Days to Decision | 345 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LJX — Test, Urine Leukocyte |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.7675 |