The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Imx(tm) D-dimer.
| Device ID | K893961 |
| 510k Number | K893961 |
| Device Name: | ABBOTT IMX(TM) D-DIMER |
| Classification | Fibrin Split Products |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Mary Zorc |
| Correspondent | Mary Zorc ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-01 |
| Decision Date | 1989-08-03 |