The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Imx2 Analyer.
| Device ID | K931970 |
| 510k Number | K931970 |
| Device Name: | ABBOTT IMX2 ANALYER |
| Classification | Analyzer, Enzyme, For Clinical Use |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Mary Spiewak |
| Correspondent | Mary Spiewak ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | JJI |
| CFR Regulation Number | 862.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-22 |
| Decision Date | 1993-06-16 |