The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Igm.
| Device ID | K983132 |
| 510k Number | K983132 |
| Device Name: | IGM |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1998-11-04 |