K023407 is an FDA 510(k) clearance for the ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II - Special Controls, product code CGX).
Submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on February 14, 2003, 127 days after receiving the submission on October 10, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K023407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2002 |
| Decision Date | February 14, 2003 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGX — Alkaline Picrate, Colorimetry, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |