The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Cea Assay.
| Device ID | K964368 |
| 510k Number | K964368 |
| Device Name: | ELECSYS CEA ASSAY |
| Classification | Calibrator, Secondary |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Contact | Mary Koning |
| Correspondent | Mary Koning BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-06-16 |
| Summary: | summary |