B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM

Antigen, Inflammatory Response Marker, Sepsis

BRAHMS AKTIENGESELLSCHAFT

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.

Pre-market Notification Details

Device IDK070310
510k NumberK070310
Device Name:B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
ClassificationAntigen, Inflammatory Response Marker, Sepsis
Applicant BRAHMS AKTIENGESELLSCHAFT 2568A RIVA ROAD SUITE 207 Annapolis,  MD  21401
ContactJonas Leichtner
CorrespondentJonas Leichtner
BRAHMS AKTIENGESELLSCHAFT 2568A RIVA ROAD SUITE 207 Annapolis,  MD  21401
Product CodeNTM  
CFR Regulation Number866.3210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-01
Decision Date2008-03-31
Summary:summary

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