The following data is part of a premarket notification filed by Brahms Aktiengesellschaft with the FDA for B R A H M S Pct Sensitive Kryptor Test System.
| Device ID | K070310 |
| 510k Number | K070310 |
| Device Name: | B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM |
| Classification | Antigen, Inflammatory Response Marker, Sepsis |
| Applicant | BRAHMS AKTIENGESELLSCHAFT 2568A RIVA ROAD SUITE 207 Annapolis, MD 21401 |
| Contact | Jonas Leichtner |
| Correspondent | Jonas Leichtner BRAHMS AKTIENGESELLSCHAFT 2568A RIVA ROAD SUITE 207 Annapolis, MD 21401 |
| Product Code | NTM |
| CFR Regulation Number | 866.3210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-01 |
| Decision Date | 2008-03-31 |
| Summary: | summary |