The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Iphenytoin Reagents And Architech Iphenytoin Calibrators With Models 1p34, And 1p34-01.
| Device ID | K080696 |
| 510k Number | K080696 |
| Device Name: | ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Contact | Carol Jochum |
| Correspondent | Carol Jochum ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-12 |
| Decision Date | 2008-09-11 |
| Summary: | summary |