K071644 is an FDA 510(k) clearance for the ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620. This device is classified as a Enzyme Immunoassay, Phenobarbital (Class II - Special Controls, product code DLZ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 12, 2007, 89 days after receiving the submission on June 15, 2007.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3660.
| 510(k) Number | K071644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2007 |
| Decision Date | September 12, 2007 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DLZ — Enzyme Immunoassay, Phenobarbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3660 |