K031856 is an FDA 510(k) clearance for the PRECISET TDM I AND PRECISET TDM II CALIBRATORS. This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 6, 2003, 51 days after receiving the submission on June 16, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K031856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2003 |
| Decision Date | August 06, 2003 |
| Days to Decision | 51 days |
| Submission Type | Abbreviated |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |