The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Creatinine.
| Device ID | K083809 |
| 510k Number | K083809 |
| Device Name: | CREATININE |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-04-07 |
| Summary: | summary |