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 | K172322 |
| 510k Number | K172322 |
| Device Name: | Atellica IM Total HCG (ThCG) |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Anoop Joy |
| Correspondent | Anoop Joy Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-01 |
| Decision Date | 2018-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600079 | K172322 | 000 |
| 00630414600062 | K172322 | 000 |
| 00630414600055 | K172322 | 000 |
| 00630414600048 | K172322 | 000 |
| 00630414600031 | K172322 | 000 |
| 00630414600024 | K172322 | 000 |
| 00630414294254 | K172322 | 000 |