The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Ca 125 Ii.
| Device ID | K972162 |
| 510k Number | K972162 |
| Device Name: | ELECSYS CA 125 II |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | BOEHRINGER MANNHEIM CORP. 9112 HAGUE RD. Indianapolis, IN 46256 |
| Contact | Leeann Chambers |
| Correspondent | Leeann Chambers BOEHRINGER MANNHEIM CORP. 9112 HAGUE RD. Indianapolis, IN 46256 |
| Product Code | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1998-03-18 |
| Summary: | summary |