K080696 is an FDA 510(k) clearance for the ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01. This device is classified as a Enzyme Immunoassay, Diphenylhydantoin (Class II - Special Controls, product code DIP).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 11, 2008, 183 days after receiving the submission on March 12, 2008.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K080696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2008 |
| Decision Date | September 11, 2008 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIP — Enzyme Immunoassay, Diphenylhydantoin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |