The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Axsym Gentamicin.
| Device ID | K935376 |
| 510k Number | K935376 |
| Device Name: | AXSYM GENTAMICIN |
| Classification | Enzyme Immunoassay, Gentamicin |
| Applicant | ABBOTT MFG., INC. ONE ABBOTT PARK Abbott Park, IL 60064 |
| Contact | Kathy Zeng |
| Correspondent | Kathy Zeng ABBOTT MFG., INC. ONE ABBOTT PARK Abbott Park, IL 60064 |
| Product Code | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-08 |
| Decision Date | 1994-06-21 |