K102568 is an FDA 510(k) clearance for the URIC ACID MODEL 3P39. This device is classified as a Acid, Uric, Uricase (colorimetric) (Class I - General Controls, product code KNK).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 6, 2011, 241 days after receiving the submission on September 7, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K102568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2010 |
| Decision Date | May 06, 2011 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KNK — Acid, Uric, Uricase (colorimetric) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1775 |