The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Cea On The Elecsys 1010.
| Device ID | K980887 |
| 510k Number | K980887 |
| Device Name: | ELECSYS CEA ON THE ELECSYS 1010 |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Patricia M Klimley |
| Correspondent | Patricia M Klimley BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-09 |
| Decision Date | 1998-06-29 |
| Summary: | summary |