The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Ca 125ii On The Elecsys 1010.
| Device ID | K980240 |
| 510k Number | K980240 |
| Device Name: | ELECSYS CA 125II ON THE ELECSYS 1010 |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Jody J Savage |
| Correspondent | Jody J Savage BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-23 |
| Decision Date | 1998-03-25 |
| Summary: | summary |