The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Imx Ca 125.
| Device ID | K964185 |
| 510k Number | K964185 |
| Device Name: | IMX CA 125 |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | ABBOTT DIAGNOSTICS 200 ABBOTT PARK RD. DEPT. 49C AP31 Abbott Park, IL 60064 -3537 |
| Contact | Joy C Sonsalla |
| Correspondent | Joy C Sonsalla ABBOTT DIAGNOSTICS 200 ABBOTT PARK RD. DEPT. 49C AP31 Abbott Park, IL 60064 -3537 |
| Product Code | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-21 |
| Decision Date | 1997-11-04 |
| Summary: | summary |