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 |