The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Atellica Im Brahms Procalcitonin (pct).
| Device ID | K181002 |
| 510k Number | K181002 |
| Device Name: | Atellica IM BRAHMS Procalcitonin (PCT) |
| Classification | Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 -5097 |
| Contact | Fatima Pacheco |
| Correspondent | Fatima Pacheco Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 -5097 |
| Product Code | PMT |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414246550 | K181002 | 000 |