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 |