The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Cea - Carcinoembryonic Antigen.
| Device ID | K081615 |
| 510k Number | K081615 |
| Device Name: | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | OLYMPUS AMERICA, INC. LISHEEHAN, O'CALLAGHAN'S MILLS Co. Clare, IE |
| Contact | Stephanie G Donnelly |
| Correspondent | Stephanie G Donnelly OLYMPUS AMERICA, INC. LISHEEHAN, O'CALLAGHAN'S MILLS Co. Clare, IE |
| Product Code | DHX |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-09 |
| Decision Date | 2009-03-18 |