The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Iphenobarbital Reagents And Architect Iphenobarbital Calibrators, Models 1p33, 1p33.
| Device ID | K081231 |
| 510k Number | K081231 |
| Device Name: | ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 049D BLDG. AP 6C-2 Abbott Park, IL 60064 -6092 |
| Contact | Carol Jochum |
| Correspondent | Carol Jochum ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 049D BLDG. AP 6C-2 Abbott Park, IL 60064 -6092 |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-01 |
| Decision Date | 2008-09-26 |
| Summary: | summary |