K033165 is an FDA 510(k) clearance for the PRECISET DAT AMPHETAMINE CALIBRATORS. This device is classified as a Calibrators, Drug Specific (Class II - Special Controls, product code DLJ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 14, 2003, 14 days after receiving the submission on September 30, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K033165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2003 |
| Decision Date | October 14, 2003 |
| Days to Decision | 14 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DLJ — Calibrators, Drug Specific |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |