The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Imx Insulin.
| Device ID | K920109 |
| 510k Number | K920109 |
| Device Name: | IMX INSULIN |
| Classification | Radioimmunoassay, Immunoreactive Insulin |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Jean Frydman |
| Correspondent | Jean Frydman ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | CFP |
| CFR Regulation Number | 862.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-10 |
| Decision Date | 1992-05-07 |