The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Atellica Im Total Hcg (thcg).
| Device ID | K192790 |
| 510k Number | K192790 |
| Device Name: | Atellica IM Total HCG (ThCG) |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Ave. Tarrytown, NY 10591 |
| Contact | Mey Lyn Vasquez |
| Correspondent | Mey Lyn Vasquez Siemens Healthcare Diagnostics Inc. 511 Benedict Ave. Tarrytown, NY 10591 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-10-30 |
| Summary: | summary |