The following data is part of a premarket notification filed by Olympus Life Science Research Europa Gmbh (europa) with the FDA for Olympus Total Bhcg Test Systen.
| Device ID | K080094 |
| 510k Number | K080094 |
| Device Name: | OLYMPUS TOTAL BHCG TEST SYSTEN |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) 3131 WEST ROYAL LANE Irving, TX 75063 |
| Contact | Stephanie Donnelly |
| Correspondent | Stephanie Donnelly OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) 3131 WEST ROYAL LANE Irving, TX 75063 |
| Product Code | DHA |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-09-03 |