The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Axsym Phenytoin Assay.
| Device ID | K935375 |
| 510k Number | K935375 |
| Device Name: | AXSYM PHENYTOIN ASSAY |
| Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
| Applicant | ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Contact | Kathy Zeng |
| Correspondent | Kathy Zeng ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Product Code | LGR |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-08 |
| Decision Date | 1994-06-21 |