The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Uric Acid Model 3p39.
| Device ID | K102568 |
| 510k Number | K102568 |
| Device Name: | URIC ACID MODEL 3P39 |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | ABBOTT LABORATORIES 1921 HURD DRIVE Irving, TX 75038 |
| Contact | Linda K Morris |
| Correspondent | Linda K Morris ABBOTT LABORATORIES 1921 HURD DRIVE Irving, TX 75038 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-07 |
| Decision Date | 2011-05-06 |
| Summary: | summary |