K080183 is an FDA 510(k) clearance for the CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 25, 2008, 60 days after receiving the submission on January 25, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K080183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2008 |
| Decision Date | March 25, 2008 |
| Days to Decision | 60 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |