The following data is part of a premarket notification filed by Brahms Aktiengesellschaft with the FDA for B-r-a-h-m-s Pct Lia.
| Device ID | K040887 |
| 510k Number | K040887 |
| Device Name: | B-R-A-H-M-S PCT LIA |
| Classification | Antigen, Inflammatory Response Marker, Sepsis |
| Applicant | BRAHMS AKTIENGESELLSCHAFT 11800 BALTIMORE AVE. SUITE 105 Beltsville, MD 20705 |
| Contact | Melissa Mahall |
| Correspondent | Melissa Mahall BRAHMS AKTIENGESELLSCHAFT 11800 BALTIMORE AVE. SUITE 105 Beltsville, MD 20705 |
| Product Code | NTM |
| CFR Regulation Number | 866.3210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-05 |
| Decision Date | 2005-01-07 |
| Summary: | summary |